Fast registration track
Order of Russian Government 430 (registration scheme for emergency COVID medical devices and IVDs, was prolongated to 2021) is expected to be prolongated until 2025 (draft of the law under Government review in this moment) as well as new products can be registered under approval process.
Full list of medical devices and IVDs in updated regulation.
Part 1. List of products from extension
| Type | Name of device | |
| 1. | 169180 | Immobile ventilator, high frequency, with electrical drive |
| 2. | 121270 | Manual ventilation device, disposable |
| 3. | 121180 | Manual ventilation device, reusable |
| 4. | 114040 | Portable ventilator, with air drive |
| 5. | 113890 | Portable ventilator, with electrical drive |
| 6. | 311390 | Portable ventilator, with air drive, high frequency |
| 7. | 314540 | Immobile ventilator, with air drive, high frequency |
| 8. | 314860 | Emergency vehicle ventilator, with air drive, high frequency |
| 9. | 318710 | CPAP mode ventilator, for home use |
| 10. | 326140 | CPAP mode ventilator, for newborns |
| 11. | 287620 | Negative pressure (suction) mode ventilator |
| 12. | 216540 | Pneumatically driven automated ventilation device, reusable |
| 13. | 232870 | ICU ventilator for newborn/adult patients |
| 14. | 232880 | ICU ventilator for newborn patients |
| 15. | 232890 | ICU ventilator, general purpose |
| 16. | 274590 | Emergency vehicle ventilator, with electrical drive |
| 17. | 275750 | A&R ventilator |
| 18. | 216260 | Pneumatically driven automated ventilation device, disposable |
| 19. | 115610 | Extracorporeal membrane oxygenator* |
| 20. | 131520 | Intravascular membrane oxygenator* |
| 21. | 142010 | Antigens for SARS coronavirus, IVD set, immunochromatographic assay, express test |
| 22. | 142100 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/AgM, IVD set, for ELISA |
| 23. | 142120 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/AgM, IVD set, for immunofluorescence assay |
| 24. | 142130 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM), IVD set, for ELISA test |
| 25. | 142150 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM), IVD set, for immunofluorescence assay |
| 26. | 142160 | SARS coronavirus, nucleic acid, IVD set, for NA test |
| 27. | 142250 | Antibodies for SARS coronavirus, immunoglobulin class A (IgA)/IgGAgM, IVD set, immunochromatographic assay, express test |
| 28. | 142260 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG), IVD set, for ELISA |
| 29. | 142280 | Antigens for SARS coronavirus, IVD set, for enzyme-linked immunosorbent assay (ELISA) |
| 30. | 142300 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG), IVD set, for immunofluorescence assay |
| 31. | 343600 | Reusable eye protective screen |
| 32. | 142020 | Antibodies for SARS coronavirus, immunoglobulin class А (IgA)/IgGAgM IVD set, control material |
| 33. | 142030 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG) IVD set, calibrator |
| 34. | 142050 | Antigens for SARS coronavirus, IVD set, calibrator |
| 35. | 142060 | Antibodies for SARS coronavirus, immunoglobulin class А (IgA)/IgGAgM IVD set, reagent |
| 36. | 142070 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG) IVD set, control material |
| 37. | 142080 | Antigens for SARS coronavirus, IVD set, control material |
| 38. | 142090 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG) IVD set, reagent |
| 39. | 142110 | Antigens for SARS coronavirus, IVD set, reagent |
| 40. | 142140 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/IgM IVD set, calibrator |
| 41. | 142170 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)AgM IVD set, control material |
| 42. | 142180 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM) IVD set, calibrator |
| 43. | 142190 | SARS coronavirus, nucleic acid, IVD set, calibrator |
| 44. | 142200 | Antibodies for SARS coronavirus, immunoglobulin class G (IgG)/IgM IVD set, reagent |
| 45. | 142210 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM) IVD set, control material |
| 46. | 142220 | SARS coronavirus, nucleic acid, IVD set, control material |
| 47. | 142230 | Antibodies for SARS coronavirus, immunoglobulin class M (IgM) IVD set, reagent |
| 48. | 142240 | SARS coronavirus, nucleic acid, IVD set, reagent |
| 49. | 142290 | Antibodies for SARS coronavirus, immunoglobulin class А (IgA)/IgG/IgM, IVD set, calibrator |
| 50. | 152850 | IVD set for extraction\isolation of nucleic acids |
| 51. | 349480 | Non-specific set for biomaterial sampling (sampling, pre-treatment and transportation) |
| 52. | 191780 | Artificial blood circulation (ABC) system, non-rolling pump type |
| 53. | 191810 | Artificial blood circulation (ABC) system, rolling pump type |
| 54. | 209090 | Extracorporeal oxygenation/ventilation system, portable |
| 55. | 104010 | Isolating overall |
| 56. | 122540 | Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile |
| 57. | 122560 | Gloves for manual examination/interventions, made of natural hevea latex, powdered |
| 58. | 129350 | Surgical gown, disposable* |
| 59. | 129380 | Surgical gown, reusable |
| 60. | 129870 | Isolating gown, reusable |
| 61. | 129880 | Isolating gown, disposable* |
| 62. | 132380 | Facial mask for respiratory protection, reusable |
| 63. | 139350 | Gloves for manual examination/interventions, made of polychloroprene, non-powdered |
| 64. | 139360 | Gloves for manual examination/interventions, made of polychloroprene, powdered |
| 65. | 141650 | Overshoes non-conductive, non-sterile* |
| 66. | 157010 | Patient’s gown, disposable* |
| 67. | 157240 | Patient’s gown, reusable |
| 68. | 164050 | Gown for interventions, disposable |
| 69. | 164070 | Gown for interventions, reusable |
| 70. | 180770 | Breathing mask, general purpose* |
| 71. | 181360 | Surgical isolating overall |
| 72. | 181520 | Surgical mask, reusable |
| 73. | 181830 | Surgical breathing mask |
| 74. | 182450 | Surgical mask, disposable* |
| 75. | 185830 | Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, non-sterile |
| 76. | 185850 | Gloves for manual examination/interventions, made of nitrile rubber, powdered |
| 77. | 188380 | Surgical overall, cuffed* |
| 78. | 205280 | Gloves for manual examination/interventions, made of vinyl, non-powdered |
| 79. | 205290 | Gloves for manual examination/interventions, made of vinyl, powdered |
| 80. | 248320 | Surgical overall, disposable, non-sterile |
| 81. | 269290 | Overshoes, watertight |
| 82. | 293810 | Overshoes, conductive, non-sterile* |
| 83. | 298450 | Gloves for manual examination/interventions, made of guayule latex, non-powdered |
| 84. | 311720 | Gloves for manual examination/interventions, made of ethylene vinyl acetate, non-powdered, non-sterile |
| 85. | 320790 | Gloves for manual examination/interventions, made of nitrile rubber, non-powdered, with anti-bacterial properties |
| 86. | 321530 | Gloves for manual examination/interventions, made of polyisoprene, non-powdered |
| 87. | 332470 | Set of overalls for surgery/examination |
| 88. | 349230 | Gloves for manual examination/interventions, made of polyisoprene, powdered |
| 89. | 351490 | Gloves for manual examination/interventions, made of natural hevea latex, non-powdered, non-sterile, with anti-bacterial properties |
| 90. | 367580 | Facial mask for respiratory protection, disposable* |
| 91. | 126370 | Infra-red thermometer for body temperature measurement, aural |
| 92. | 126390 | Infra-red thermometer for body temperature measurement, skin-touch type |
| 93. | 184110 | Medical thermometer with LCD display, disposable |
| 94. | 190030 | Electronic thermometer (AC mains power required) for continuous temperature measurement |
| 95. | 190040 | Electronic thermometer (battery power required) for continuous temperature measurement |
| 96. | 213720 | Thermometer for body temperature measurement, capillary type, alcohol filled |
| 97. | 213740 | Infra-red thermometer for body temperature measurement, capillary type, mercury filled |
| 98. | 254890 | Optical fiber-based thermometer with temperature probe |
| 99. | 266210 | Thermometer for body temperature measurement, electronic, for intermittent measurement mode |
| 100. | 300390 | Thermometer for body temperature measurement, with colour coded temperature indication |
| 101. | 335240 | Thermometer for body temperature measurement, capillary type, Gallium alloy filled |
| 102. | 339240 | Medical thermometer with LCD display, reusable |
| 103. | 341680 | Patient thermometer wireless, reusable |
| 104. | 341690 | Patient thermometer wireless, disposable |
| 105. | 358080 | Infra-red thermometer for body temperature measurement, skin-touch/aural type |
| 106. | 108170 | Outpatient registration device for body temperature monitoring |
| 107. | 292390 | Electronic micropipette |
| 108. | 216020 | IVD semi-automatic thermocyclic nucleic acid thermocycler of laboratory grade |
| 109. | 215980 | IVD automatic thermocyclic nucleic acid thermocycler of laboratory grade |
| 110. | 347450 | IVD thermocyclic nucleic acid thermocycler for use near patient |
| 111. | 216000 | IVD manual thermocyclic nucleic acid thermocycler |
| 112. | 318650 | Automatic magnetic IVD particle separation device |
| 113. | 228180 | Exchange window |
| 114. | 318660 | Automatic device for preparation of IVD nucleic acids samples |
| 115. | 207000 | IVD virus transport medium |
| 116. | 340600 | Disposable container for IVD analysis |
| 117. | 259780 | Non-specialized IVD sample collection sterile container with no additives |
| 118. | 108750 | General-purpose sterile laboratory container |
| 119. | 259720 | Non-specialized, non-sterile IVD sampling container with no additives |
| 120. | 293350 | IVD vacuum collection tube for blood samples with dextrose B citrate (ACD-B) |
| 121. | 293360 | IVD vacuum collection tube for blood samples with K3EDTA and sodium fluoride |
| 122. | 293370 | IVD vacuum collection tube for blood samples with no additives |
| 123. | 293400 | IVD vacuum collection tube for blood samples with potassium oxalate and sodium fluoride |
| 124. | 293420 | IVD vacuum collection tube for blood samples with sodium heparin |
| 125. | 293440 | IVD vacuum collection tube for blood samples with dextrose A citrate (ACD-A) |
| 126. | 293450 | IVD vacuum collection tube for blood samples with ammonium heparin and separation gel |
| 127. | 293460 | IVD vacuum collection tube for blood samples with lithium heparin and lithium iodoacetate |
| 128. | 293470 | IVD vacuum collection tube for blood samples with CPhDA* |
| 129. | 293480 | IVD vacuum collection tube for blood samples with lithium heparin and separation gel |
| 130. | 293500 | IVD vacuum collection tube for blood samples with K2EDTA* |
| 131. | 293550 | Vacuum container for IVD saliva samples with sodium azide |
| 132. | 264440 | IVD centrifugal sterile tube |
| 133. | 134590 | Cryobiological container |
| 134. | 167480 | IVD non-vacuum collection tube for blood samples with no impurities, |
| 135. | 259790 | IVD non-specialized tissue collection container with formalin solution |
| 136. | 264460 | IVD centrifugal non-sterile tube |
| 137. | 167550 | IVD non-vacuum collection tube for blood samples with sodium citrate |
| 138. | 167430 | IVD non-vacuum collection tube for blood samples with EDTA* |
| 139. | 167440 | IVD non-vacuum collection tube for blood samples with separation gel |
| 140. | 108710 | General-purpose reusable laboratory container |
| 141. | 293660 | IVD vacuum collection tube for blood samples with K3EDTA* |
| 142. | 293570 | IVD vacuum collection tube for blood samples with coagulation activator |
| 143. | 167450 | IVD non-vacuum collection tube for blood samples with lithium heparin |
| 144. | 293760 | IVD vacuum collection tube for blood samples with lithium heparin |
| 145. | 293540 | IVD vacuum collection tube for blood samples with sodium citrate |
| 146. | 343590 | Reusable facial protective screen |
| 147. | 107700 | Facial protective screen* |
| 148. | 274530 | Eye protective screen* |
| 149. | 127430 | Ultrasonic respiratory air/gas humidifier |
| 150. | 152090 | Humidifier for respiratory mixtures with a heating element |
| 151. | 173070 | Humidifier for respiratory mixtures without a heating element |
| 152. | 318730 | Non-sterile disposable bacterial filter for medical gases |
| 153. | 324930 | Non-sterile reusable bacterial filter for medical gases |
| 154. | 165140 | Disposable connector for respiratory circuits |
| 155. | 165230 | Reusable connector for respiratory circuits |
| 156. | 185620 | Disposable moisture collector for artificial lung ventilation devices |
| 157. | 185630 | Reusable moisture collector for artificial lung ventilation devices |
| 158. | 109720 | Reusable facial mask of the continuous/two-phase positive airway pressure device, |
| 159. | 109740 | Oral mask for artificial ventilation with continuous/two-phase positive pressure |
| 160. | 109710 | Disposable facial mask of the continuous/two-phase positive airway pressure device, |
| 161. | 271370 | Reusable mask for artificial lung ventilation |
| 162. | 271390 | Disposable mask for artificial lung ventilation |
| 163. | 110230 | Reusable tube/mask connector for respiratory circuits |
| 164. | 136690 | Connector with plug for quick connection of medical air cylinders |
| 165. | 136820 | Connector for quick connection of medical air cylinders with f-port |
| 166. | 151440 | Reusable Y-shaped connector for respiratory circuits |
| 167. | 298870 | Connector for quick connection in the helium-oxygen mixture supply system with f-port |
| 168. | 298880 | Connector for quick connection in the helium-oxygen mixture supply system, with m-port |
| 169. | 275840 | Connector for quick connection in the exhaust system of anaesthetic gases with m-port |
| 170. | 250830 | Connector for NOS quick connection with f-port |
| 171. | 250770 | Connector for NOS quick connection with m-port |
| 172. | 250740 | Connector for hyponitrous oxide quick connection with f-port |
| 173. | 250710 | Connector for hyponitrous oxide quick connection with m-port |
| 174. | 283370 | Disposable bag for respiratory circuits |
| 175. | 283460 | Reusable bag for respiratory circuits |
| 176. | 283480 | Reusable gas flow sensor for breathing system |
| 177. | 105850 | Nasal cannula for oxygen supply during mechanical ventilation with continuous positive pressure |
| 178. | 136410 | Standard nasal cannula for oxygen supply* |
| 179. | 185520 | Respiratory tube holder |
| 180. | 139780 | Reusable spacer for nebulizer or inhaler |
| 181. | 345540 | Disposable spacer for nebulizer or inhaler |
| 182. | 298900 | Helium and oxygen mixer for breathing mixture |
| 183. | 344690 | Oxygen/air gas mixer for emergency aid |
| 184. | 132340 | Respiratory airway cleaning/suction tube for emergencies |
| 185. | 135720 | Endobronchial tube |
| 186. | 136260 | Disposable standard endotracheal tube |
| 187. | 136270 | Reusable standard endotracheal tube |
| 188. | 136490 | Reusable standard tracheostomy tube |
| 189. | 136500 | Disposable standard tracheostomy tube |
| 190. | 136850 | Medical air low-pressure tube |
| 191. | 169050 | Reusable reinforced endotracheal tube |
| 192. | 169080 | Disposable reinforced tracheostomy tube |
| 193. | 169100 | Disposable reinforced endotracheal tube |
| 194. | 183640 | Coaxial tube for hyponitrous oxide cylinder* |
| 195. | 191040 | Disposable suction/flushing tube |
| 196. | 218780 | Endotracheal antibacterial tube* |
| 197. | 250810 | Low-pressure tube for hyponitrous oxide |
| 198. | 269300 | Laser-resistant endotracheal tube |
| 199. | 271240 | Disposable respiratory tube for gas collection/monitoring |
| 200. | 274010 | Aerosol supply tube* |
| 201. | 275760 | Tube for evacuating waste anaesthetic gases |
| 202. | 279070 | Endotracheal tube with suction cup |
| 203. | 283260 | Breathing system tube |
| 204. | 298800 | Disposable vacuum tube |
| 205. | 298830 | Reusable vacuum tube |
| 206. | 301700 | Endotracheal tube for high-frequency mechanical ventilation |
| 207. | 332650 | Disposable sterile respiratory tube for gas collection/monitoring |
| 208. | 332660 | Reusable respiratory tube for gas collection/monitoring |
| 209. | 333030 | Tube for monitoring pressure to the artificial blood circulation (ABC) system |
| 210. | 333510 | Reusable respiratory tube for inspiratory/expiratory tube |
| 211. | 334110 | Spirometry tube/lung function assessment |
| 212. | 348290 | Duct cuff inflation tube |
| 213. | 349970 | Customized tracheostomy tube |
| 214. | 351410 | Reusable low-pressure gas tube for general use |
| 215. | 354450 | Disposable non-sterile tube for inspiratory/expiratory extension |
| 216. | 357210 | Reusable reinforced tracheostomy tube |
| 217. | 360480 | Disposable sterile tube for inspiratory/expiratory extension |
| 218. | 207560 | Reusable adapter for inhalation therapy |
| 219. | 110260 | Replaceable filter for heat/moisture exchanger |
| 220. | 173800 | Protective filter for tracheostomy* |
| 221. | 181090 | Surgical instrument compressed air filter |
| 222. | 218750 | Non-sterile heat/moisture exchanger/bacterial filter |
| 223. | 172720 | Reusable oropharyngeal airway |
| 224. | 172730 | Disposable oropharyngeal airway |
| 225. | 254040 | Disposable tracheal airway with oesophageal obturator |
| 226. | 254120 | Reusable oesophageal airway |
| 227. | 254170 | Disposable airway with oesophageal obturator |
| 228. | 254240 | Reusable tracheal airway with oesophageal obturator |
| 229. | 254280 | Reusable nasopharyngeal airway |
| 230. | 254300 | Disposable nasopharyngeal airway |
| 231. | 289900 | Reusable stylet for airway |
| 232. | 290000 | Disposable stylet for airway* |
| 233. | 318100 | Device for pumping air out of a cuff for a laryngeal airway |
| 234. | 318110 | Introducer for laryngeal airway |
| 235. | 283330 | Disposable mouthpiece for respiratory circuits |
| 236. | 283380 | Reusable mouthpiece for respiratory circuits |
| 237. | 325840 | Filter/mouthpiece for checking lung function* |
| 238. | 350590 | Valsalva’s manoeuvre standard mouthpiece* |
| 239. | 351540 | Cardiopulmonary resuscitation mouthpiece/cover |
| 240. | 364520 | Valsalva’s manoeuvre manometric mouthpiece |
| 241. | 172910 | Tracheal tube cuff* |
| 242. | 172970 | Tracheal tube cuff expander |
| 243. | 173780 | Tracheostomy tube cuff |
| 244. | 289870 | Pump for manual injection of air into the cuff of the endotracheal tube |
| 245. | 289980 | Endotracheal tube cuff pressure monitor |
| 246. | 289880 | Reusable endotracheal tube introducer |
| 247. | 289990 | Disposable endotracheal tube introducer |
| 248. | 172930 | Vacuum regulator in aspiration system for trachea |
| 249. | 108960 | Disposable end-expiratory positive pressure valve |
| 250. | 109060 | Reusable end-expiratory positive pressure valve |
| 251. | 124510 | Disposable mechanical expiratory valve |
| 252. | 124630 | Reusable mechanical expiratory valve |
| 253. | 135690 | Endobronchial valve |
| 254. | 135700 | Endobronchial valve catheter* |
| 255. | 135710 | Endobronchial valve sizing kit |
| 256. | 168130 | Reusable embedded check valve |
| 257. | 168140 | Disposable embedded check valve |
| 258. | 236910 | Exhalation valve with RF sensor* |
| 259. | 249420 | Haemostatic valve obturator* |
| 260. | 260200 | Connector for needleless connection with direct-flow valve |
| 261. | 262380 | Reusable non-reversible valve |
| 262. | 321960 | Disposable non-reversible valve |
| 263. | 337110 | Resistance valve for cardiopulmonary resuscitation, for inhalation/exhalation |
| 264. | 327780 | Medical gas flowmeter with Thorpe tube |
| 265. | 151450 | Disposable Y-shaped connector for respiratory circuits |
| 266. | 182020 | Surgical instrument compressed air quick connector with f-port |
| 267. | 182030 | Surgical instrument compressed air quick connector with m-port |
| 268. | 256770 | Reusable low-pressure tube connector |
| 269. | 275690 | Connector for quick connection in the exhaust system of anaesthetic gases with f-port |
| 270. | 298760 | Vacuum quick connector with f-port |
| 271. | 298770 | Vacuum quick connector with m-port |
| 272. | 327610 | Disposable non-sterile tube/mask connector for respiratory circuits |
| 273. | 327640 | Disposable sterile tube/mask connector for respiratory circuits |
| 274. | 115570 | Extracorporeal vesiculate oxygenator* |
| 275. | 191500 | Air bubble/fluid level detector for the artificial blood circulation (ABC) system |
| 276. | 191740 | The air/foam detector for the artificial blood circulation (ABC) system |
| 277. | 191920 | Cardiotomy reservoir* |
| 278. | 191770 | Centrifugal pump for the artificial blood circulation (ABC) system |
| 279. | 264520 | Centrifugal pump for the artificial blood circulation (ABC) system with power supply |
| 280. | 115660 | Device for extracorporeal monitoring of blood gases/pH |
| 281. | 191440 | Cardioplegic solution adapter* |
| 282. | 191560 | Set of tubes for the artificial blood circulation (ABC) system |
| 283. | 327170 | General-purpose laboratory research tablet |
| 284. | 327110 | IVD microplate* |
| 285. | 209360 | Mobile unit for creating a laminar flow |
| 286. | 182750 | Surgical unit for creating a laminar flow |
| 287. | 152700 | Highly efficient stationary air filter |
| 288. | 152690 | Mobile highly effective air filtering purifier |
| 289. | 131980 | UV bactericidal lamp |
| 290. | 347590 | UV light disinfection system |
| 291. | 157200 | Pulse oximetry patient monitoring system module |
| 292. | 150020 | Pulse oximeter with power supply |
| 293. | 149980 | Battery powered pulse oximeter |
| 294. | 218410 | Telemetry pulse oximeter |
| 295. | 220960 | Thermographic camera |
| 296. | 126320 | Infrared Thermographic System |
| 297. | 157680 | Medical bedside console with communications |
| 298. | 259390 | Universal console with communications |
| 299. | 259380 | Universal console with communication leads and ceiling mount |
| 300. | 188360 | High-flow infusion pump with the ability to heat the injected media |
| 301. | 288180 | Elastomeric infusion pump* |
| 302. | 124530 | Reusable mechanical general-purpose infusion pump |
| 303. | 183030 | Multi-channel general-purpose infusion pump |
| 304. | 260420 | General-purpose infusion pump with power supply |
| 305. | 329460 | Battery-powered general-purpose infusion pump |
| 306. | 333950 | Disposable mechanical general-purpose infusion pump |
| 307. | 324350 | Disposable flexible, single-use video bronchoscope |
| 308. | 179300 | Reusable flexible, single-use video bronchoscope |
| 309. | 143930 | Hard bronchoscope |
| 310. | 179100 | Flexible optical fiber bronchoscope |
| 311. | 182740 | Surgical system for suction/irrigation |
| 312. | 358710 | General-purpose electric aspiration surgical system |
| 313. | 358690 | General-purpose pneumatic aspiration surgical system |
| 314. | 228190 | Laminar air tent |
| 315. | 157130 | Multifunctional patient monitoring system module |
| 316. | 190840 | System for monitoring physiological parameters of several patients |
| 317. | 190850 | System for monitoring physiological parameters of individual patient |
| 318. | 143910 | Blood refrigerator |
| 319. | 215850 | Pharmaceutical refrigerator |
| 320. | 261620 | Basic laboratory refrigerator |
| 321. | 321680 | Blood refrigerator/freezer |
| 322. | 352570 | Laboratory refrigerator/freezer |
| 323. | 352580 | Pharmacy refrigerator/freezer |
| 324. | 120210 | Mechanical hospital bed |
| 325. | 136210 | Standard hospital bed with electrical drive |
| 326. | 131200 | Hospital bed with hydraulic drive |
| 327. | 248410 | Microsample centrifuge |
| 328. | 214590 | Cytological centrifuge |
| 329. | 117910 | High speed floor-mounted centrifuge |
| 330. | 143900 | Blood bank centrifuge |
| 331. | 260430 | General-purpose centrifuge |
| 332. | 274470 | Floor-mounted low speed centrifuge without cooling |
| 333. | 274480 | Floor-mounted low speed centrifuge with cooling |
| 334. | 261720 | Laboratory thermostat |
| 335. | 260440 | General-purpose thermostat |
| 336. | 232840 | Laboratory thermostat for clean rooms |
| 337. | 261300 | Laboratory water bath with shaking action |
| 338. | 335060 | Laboratory thermostatic stirrer |
| 339. | 327810 | Medical gas flowmeter, with dial |
| 340. | 327750 | Medical gas flowmeter with Bourdon tube pressure gauge |
| 341. | 156250 | Respiratory oxygen therapy system |
| 342. | 191160 | Stationary oxygen concentrator |
| 343. | 113810 | Portable oxygen concentrator |
| 344. | 292810 | Pipette tip* |
| 345. | 352690 | IVD pipette tip* |
| 346. | 327180 | IVD microplate-film* |
| 347. | 335550 | Tray for multi-channel dispensers |
| 348. | 293530 | IVD vacuum collection tube for blood samples with no additives/metal impurities |
| 349. | 272240 | Antiseptic cloth* |
| 350. | 261820 | Disposable general-purpose applicator/swab with absorbent tip, single use |
| 351. | 186000 | IVD automatic immunochemiluminescent analyzer |
| 352. | 109770 | Detergent/cleaning IVD-solution for automated/semi-automated systems |
| 353. | 160170 | Buffer wash solution for automatic immunochemiluminescent analyzers |
| 354. | 231970 | Substrate solution for automatic immunochemiluminescent analyzers |
| 355. | 231790 | IVD flushing solution/flushing buffer for immunochemistry |
| 356. | 324430 | Disposable reaction cuvettes/cuvettes for IVD laboratory analyser |
| 357. | 324440 | Reusable reaction cuvettes/cuvettes for IVD laboratory analyser |
| 358. | 216350 | Stationary electronic blood pressure monitor with automatic air inflation |
| 359. | 216560 | Electronic monitor, automatic, portable, with finger cuff blood pressure |
| 360. | 216630 | Electronic monitor, automatic, portable, with shoulder/wrist cuff blood pressure |
| 361. | 218430 | Telemetry blood pressure meter |
| 362. | 206980 | Kit for collecting and transporting samples with viruses |
| 363. | 347240 | Oral oropharyngeal specimen collection kit |
2. Products are going to be included (link to Government review official page):
| No. | Code | Name of device |
| 1 | 113940 | IVD immunofluorescence analyzer, near patient use, mains supply |
| 2 | 113990 | IVD immunofluorescence analyzer, near patient use, battery supply |
| 3 | 114060 | IVD immunological photometric analyzer, battery supply |
| 4 | 261440 | IVD immunofluorescence analyzer, laboratory, automatic |
| 5 | 325350 | IVD immunofluorescence/spectrophotometric analyzer, near patient use |
| 6 | ||
| 7 | IVD nucleic acid sequencer, dideoxynucleotide chain-termination method |
|
| 8 | 355870 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class A (IgA)/IgG/IgM/, IVD set, ELISA |
| 9 | 355880 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin M (IgM), IVD set, immunochromatographic assay, rapid test |
| 10 | 355890 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin G (IgG), IVD set, immunochromatographic assay, rapid test |
| 11 | 355900 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class A (IgA), IVD set, ELISA |
| 12 | 355910 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD set, immunofluorescence assay, rapid test |
| 13 | 355920 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD set, immunofluorescence assay |
| 14 | 355930 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class G (IgG)/IgM, IVD set, immunofluorescence assay |
| 15 | 355940 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD set, ELISA |
| 16 | 355950 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class G (IgG), IVD set, ELISA |
| 17 | 355960 | Total antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD set, ELISA |
| 18 | 355970 | Antibodies for coronavirus 2 (SARS-CoV-2), immunoglobulin class M (IgM), IVD set, ELISA |
| 19 | 356740 | Antibodies for SARS coronavirus 2, immunoglobulin class M (IgM), IVD set, CLIA |
| 20 | 356750 | Antibodies for SARS coronavirus 2, immunoglobulin class G (IgG), IVD set, CLIA |
| 21 | 356760 | Antibodies for SARS coronavirus 2, immunoglobulin G (IgG)/IgM, IVD set, immunochromatographic assay, rapid test |
| 22 | 356770 | SARS coronavirus 2, nucleic acid, IVD, control material |
| 23 | 356780 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD, control material |
| 24 | 356790 | Total antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD, control material |
| 25 | 356800 | Total antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD, reagent |
| 26 | 356810 | Total antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD, calibrator |
| 27 | 356820 | Total antibodies for SARS coronavirus 2 (SARS-CoV-2) IVD set, CLIA |
| 28 | 356830 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class G (IgG), IVD, calibrator |
| 29 | 356840 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class G (IgG)/IgM, IVD set, immunofluorescence assay, rapid test |
| 30 | 356850 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class A (IgA)/IgM, IVD set, ELISA |
| 31 | 356860 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class M (IgM), IVD set, immunofluorescence assay |
| 32 | 367750 | Antibodies for SARS coronavirus 1, immunoglobulin class M (IgM), IVD, reagent |
| 33 | 367760 | Antibodies for SARS coronavirus 1, immunoglobulin class G (IgG), IVD, reagent |
| 34 | 367800 | Antibodies for SARS coronavirus 1, immunoglobulin A (IgA)/IgG/IgM, IVD set, immunochromatographic assay, rapid test |
| 35 | 368680 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class G (IgG)/IgM, IVD set, biochip assay |
| 36 | 368770 | Antigens for SARS coronavirus 1/2 (SARS-CoV-1/SARS-CoV-2), IVD set, immunochromatographic assay, rapid test |
| 37 | 368850 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class A (IgA)/IgG/IgM/, IVD set, agglutination test |
| 38 | 369220 | Antibodies for SARS coronavirus 1, immunoglobulin class А (IgA)/IgG/IgM, IVD, reagent |
| 39 | 369230 | Antibodies for SARS coronavirus 1, immunoglobulin class А (IgA)/IgG/IgM, IVD, calibrator |
| 40 | 369240 | Antibodies for SARS coronavirus 1, immunoglobulin class G (IgG)/IgM IVD, reagent |
| 41 | 369510 | Antigens for SARS coronavirus 1, IVD, reagent |
| 42 | 369570 | Antibodies for SARS coronavirus 1, immunoglobulin class А (IgA)/IgG/IgM, IVD, control material |
| 43 | 369580 | Antibodies for SARS coronavirus 1, immunoglobulin class M (IgM), IVD, calibrator |
| 44 | 369590 | SARS coronavirus 1, nucleic acid, IVD, calibrator |
| 45 | 369600 | Antibodies for SARS coronavirus 1, immunoglobulin class M (IgM), IVD, control material |
| 46 | 369610 | SARS coronavirus 1, nucleic acid, IVD, reagent |
| 47 | 369620 | Antibodies for SARS coronavirus 1, immunoglobulin class G (IgG)/IgM, IVD set, immunofluorescence assay |
| 48 | 369630 | Total antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD set, magnetic immunoassay |
| 49 | 369880 | Antibodies for SARS coronavirus 1, immunoglobulin class G (IgG)/IgM IVD, calibrator |
| 50 | 370080 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class G (IgG), IVD, control material |
| 51 | 370090 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD set, immunochromatographic assay, rapid test |
| 52 | 370100 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class G (IgG), IVD set, immunofluorescence assay |
| 53 | 370110 | SARS coronavirus 2, nucleic acid, IVD set, NA test |
| 54 | 372230 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class M (IgM), IVD, calibrator |
| 55 | 372580 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class G (IgG)/IgM, IVD, control material |
| 56 | 372640 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class M (IgM), IVD, control material |
| 57 | 372850 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), IgA/IgG/IgM, IVD set, immunochromatographic assay, rapid test |
| 58 | 373130 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class A (IgA), IVD set, CLIA |
| 59 | 373770 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class A (IgA), IVD set, immunochromatographic assay, rapid test |
| 60 | 373780 | Antibodies for SARS coronavirus 2 (SARS-CoV-2), immunoglobulin class A (IgA)/IgG, IVD set, immunochromatographic assay, rapid test |
| 61 | 373810 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD, control material |
| 62 | 374540 | Antigen indicator for SARS coronavirus 2 (SARS-CoV-2), IVD, foaming agent |
| 63 | 374570 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD, calibrator |
| 64 | 374580 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD, reagent |
| 65 | 374590 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD set, CLIA |
| 66 | 374930 | Nucleic Acid Detection System for SARS Coronavirus 2 (SARS-CoV-2), IVD |
| 67 | 375010 | Antigens for SARS coronavirus 2/Influenza virus A/B, IVD set, immunochromatographic assay, rapid test |
| 68 | 375090 | Neutralizing antibodies for SARS coronavirus 2, IVD set, immunofluorescence assay, rapid test |
| 69 | 375160 | Neutralizing antibodies for SARS coronavirus 2, IVD set, CLIA |
| 70 | 375330 | SARS coronavirus 2/Influenza virus A/B nucleic acid, IVD set, NA test |
| 71 | 375860 | Total antibodies for SARS coronavirus 2, IVD set, immunochromatographic assay, rapid test |
| 72 | 376420 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD set, magnetic immunoassay |
| 73 | 376590 | Neutralizing antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD set, immunochromatographic assay, rapid test |
| 74 | 376950 | Neutralizing antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD set, ELISA |
| 75 | 377140 | Total antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD set, magnetic immunoassay, rapid test |
| 76 | 377360 | Total/neutralizing antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD set, immunochromatographic assay, self-test |
| 77 | 377370 | Neutralizing antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD set, immunochromatographic assay, self-test |
| 78 | 377880 | Antigens for SARS coronavirus 2 (SARS-CoV-2), IVD set, immunochromatographic assay, self-test |
| 79 | 378010 | Total/neutralizing antibodies for SARS coronavirus 2 (SARS-CoV-2), IVD set, immunochromatographic assay, rapid test |
| 80 | 378200 | Neutralizing antibodies for SARS coronavirus 2, IVD set, nephelometric/turbidimetric assay |
| 81 | 378840 | Antibodies for SARS coronavirus 2, immunoglobulin class A (IgA)/IgM, IVD set, CLIA |
| 82 | 379290 | Antigen for SARS-CoV-2, IVD set, electrometric assay, rapid test |
| 83 | 379360 | Antibodies for SARS-CoV-2, immunoglobulin class G (IgG), IVD set, immunochromatographic assay, self-test |
| 84 | 379590 | Neutralizing antibodies for SARS-CoV-2, immunoglobulin class G (IgG)/IgM, IVD set, immunochromatographic assay, rapid test |
________________________
Updated 08th of NOV 2021
(c) Company BW, LLC (Beawire trademark)