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Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR)
EUDAMEDClass IVD General (EU MDR)
Ref ID017
Identity
- Device Name
- Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR) EUDAMED
- Model / Reference
- ID017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012863 EUDAMED
- Basic UDI-DI
- B-06974323012863 EUDAMED
- EMDN Code
- W0106010116 OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Human MTHFR Gene Polymorphism Detection Kit (Fluorometric PCR) by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in…
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-06974323012863 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 0cfdd7dd-a842-4cb6-81f6-3c8973f95185 61 fields · synced Jul 10, 2026