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Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence P…
EUDAMEDClass IVD General (EU MDR)
Ref 18-01-0016Model 24 Tests/kit
Identity
- Trade Name
- Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- 24 Tests/kit EUDAMED18-01-0016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974674892565 EUDAMED
- Basic UDI-DI
- B-06974674892565 EUDAMED
- EMDN Code
- W0106010199 MONOGENETIC DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence P… by Shenzhen Zijian Biotechnology Co., Ltd — Class IVD General — IVDD — listed…
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-06974674892565 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Zijian Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000022829
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a8daf683-2f37-4dfa-9edf-41b2a53490fe 61 fields · synced Jun 18, 2026