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Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Detection Kit (Nephelomet…
EUDAMEDClass IVD General (EU MDR)
Ref 32026004Model 25 testsRef 32080004Model 2*25 tests
Identity
- Device Name
- Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Detection Kit (Nephelometry) EUDAMED
- Model / Reference
- 25 tests EUDAMED32026004 EUDAMED2*25 tests EUDAMED32080004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334804178 EUDAMED06950334802242 EUDAMED
- Basic UDI-DI
- B-06950334804178 EUDAMEDB-06950334802242 EUDAMED
- EMDN Code
- W01021112 ANTI-CYCLIC CITRULLINATED PEPTIDE 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
Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Detection Kit (Nephelomet… 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-06950334804178 | 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 9c23f263-7226-49d3-9df2-6d2389191fa1 61 fields · synced Oct 6, 2026
- EUDAMED c1d1e753-3e18-45b2-a46b-0caebc2c903b 61 fields · synced May 18, 2026