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D-Dimer Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32026001Model 25 testsRef 32080001Model 2*25 tests
Identity
- Trade Name
- D-Dimer Detection Kit (Nephelometry) EUDAMED
- Device Name
- D-Dimer Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 25 tests EUDAMED32026001 EUDAMED2*25 tests EUDAMED32080001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334804024 EUDAMED06950334802167 EUDAMED
- Basic UDI-DI
- B-06950334804024 EUDAMEDB-06950334802167 EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
D-Dimer 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-06950334804024 | 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 df3e3e19-6bdb-4ad0-8c36-981a00c2d072 61 fields · synced Jul 16, 2026
- EUDAMED da4a15d3-c42f-47cf-b82a-66b8c9d5315f 61 fields · synced May 18, 2026