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C-Reactive Protein (CRP) Detection Kit (Nephelometry)
EUDAMEDClass B (EU MDR)
Ref 32080146
Identity
- Trade Name
- C-Reactive Protein (CRP) Detection Kit (Nephelometry) EUDAMED
- Device Name
- C-Reactive Protein (CRP) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 32080146 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334821502 EUDAMED
- Basic UDI-DI
- 69503348PA042HZ EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Bulgaria 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
New Device
No
EUDAMED
C-Reactive Protein (CRP) Detection Kit (Nephelometry) by Genrui Biotech Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69503348PA042HZ | Class B | 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 (1)
- EUDAMED fbdb4da6-ca98-4d69-8777-d31066b21be9 61 fields · synced Jun 19, 2026