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Fibrinogen Degradation Product (FDP) Detection Kit (Nephelometry)
EUDAMEDClass IVD General (EU MDR)
Ref 32026051Model 25 testsRef 32080051Model 2*25 tests
Identity
- Device Name
- Fibrinogen Degradation Product (FDP) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 25 tests EUDAMED32026051 EUDAMED2*25 tests EUDAMED32080051 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334803485 EUDAMED06950334803492 EUDAMED
- Basic UDI-DI
- B-06950334803485 EUDAMEDB-06950334803492 EUDAMED
- EMDN Code
- W0103020502 FIBRINOGEN DEGRADATION PRODUCTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Cyprus 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
Fibrinogen Degradation Product (FDP) Detection Kit (Nephelometry) by Genrui Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED
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-06950334803485 | 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 a1a81d2c-747f-47e1-a7fd-5c6fea3c55b8 61 fields · synced Aug 1, 2026
- EUDAMED 527accdf-ded9-4024-8f8e-83f8e2f19db6 61 fields · synced May 18, 2026