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Immunoglobulin M (IgM) Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32080011Model 2*25 testsRef 32027192
Identity
- Trade Name
- Immunoglobulin M (IgM) Detection Kit (Nephelometry) EUDAMED
- Device Name
- Immunoglobulin M (IgM) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 2*25 tests EUDAMED32080011 EUDAMED32027192 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334802273 EUDAMED06950334819677 EUDAMED
- Basic UDI-DI
- B-06950334802273 EUDAMEDB-06950334819677 EUDAMED
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Cyprus EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Immunoglobulin M (IgM) Detection Kit (Nephelometry) by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06950334802273 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f073fbad-ff04-46da-8319-aed6721e4ad2 61 fields · synced Jul 19, 2026
- EUDAMED e3fea812-b34b-4744-9d2a-8c8b71dbff23 61 fields · synced Jul 19, 2026