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

* The creation of a new code type has been proposed for consideration