June 24, 2022
The first list of type codes under Decree No. 552 has been published
On the website of the Federal Service Rosddravnadzor, the first list of type codes to the Decree of the Government of the Russian Federation No. 552 dated 01.04.2022 has been published (On approval of the specifics of circulation, including the specifics of the state registration of medical devices in the event of their defectiveness or the risk of defectiveness in connection with the introduction of restrictive economic measures against the Russian Federation). This Decree establishes special rules of state registration for a special list of medical devices, and simplifies the introduction of changes for domestically manufactured products in connection with the introduction of restrictive economic measures against the Russian Federation.
The first list was published in accordance with Minute No. 1 of the meeting of the Interdepartmental Commission on the formation of a list of types of medical devices. This Commission is responsible for the formation, as well as the addition or exclusion, of type codes thereof.
Type codes in the list:
| Type (code) | Name of device |
| 107660 | Mass spectrometry IVD analyser, automatic |
| 107670 | Mass spectrometry IVD analyser, semi-automatic |
| 209280 | Device for preparation of IVD test, automatic |
| 261700 | Laboratory shaker |
| 318650 | Automatic magnetic particle separation IVD device |
| 325350 | Immunofluorescence/spectrophotometric IVD analyser for near-patient use |
| 339870 | Nucleic acid IVD sequencer, sequence after Singer |
| 190110 | Succinilacetone IVD, reagent |
| 194750 | Multiple amino acids/metabolites of carnitine IVD, reagent |
| 198560 | Multiple steroid hormones IVD, set, mass-spectrometric analysis |
| 339500 | Multiple amino acids/metabolites of carnitine IVD, set, mass spectrometric analysis/liquid chromatography |
| 192300 | Multiple amino acids/metabolites of carnitine IVD, set, mass-spectrometric analysis |
| 128100 | Neonatal thyroxine (neonatal T4) IVD, set, immunofluorescence analysis |
| 128270 | Neonatal thyroxine (neonatal T4) IVD, set, immunoenzyme analysis (IFA) |
| 103010 | Free cortisol IVD, set, enzyme-linked immunosorbent assay (ELISA) |
| 205040 | General cortisol IVD, control material |
| 205060 | General cortisol IVD, reagent |
| 231180 | Adrenocorticotropic hormone (ACTH) IVD, set, immunohistochemical reaction with enzyme method |
| 231220 | Adrenocorticotropic hormone (ACTH) IVD, antibodies |
| 231230 | Adrenocorticotropic hormone (ACTH) IVD, set, radioimmunoassay (RIA) |
| 231250 | Adrenocorticotropic hormone (ACTH) IVD, calibrator |
| 231260 | Adrenocorticotropic hormone (ACTH) IVD, set, immunochemilominescence analysis |
| 231290 | Adrenocorticotropic hormone (ACTH) IVD, control material |
| 304500 | 17-hydroxycorticoids IVD, reagent |
| 275570 | Aldosterone IVD, control material |
| 275580 | Aldosterone IVD, set, radioimmunoassay analysis (RIA) |
| 275610 | Aldosterone IVD, reagent |
| 336570 | Aldosterone IVD, set, immunochemilominescence analysis |
| 304460 | 17-hydroxyprogesterone IVD, set, enzyme spectrophotometric analysis |
| 304510 | 17-hydroxyprogesterone IVD, set, radioimmunoassay analysis (RIA) |
| 192830 | Multiple orthopoxviruses nucleic acid IVD, calibrator |
| 196790 | Multiple orthopoxviruses nucleic acid IVD, control material |
| 196800 | Multiple orthopoxviruses nucleic acid IVD, set, for NA test |
| 196810 | Multiple orthopoxviruses nucleic acid IVD, reagent |
| 334260 | Multiple orthopoxviruses antigens IVD set, enzyme-linked immunosorbent assay (ELISA) |
| 349780 | Multiple orthopoxviruses antibodies IVD, reagent |
| - * | Multiple orthopoxviruses antigens IVD, set, method dotimmunoanalysis , express analysis |
