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Anti cyclic citrullinated peptide antibody (CCP) Test kit (Latex Immunoturbidim…
EUDAMEDClass IVD General (EU MDR)
Ref R1:18mL×4 R2:6mL×4（709）
Identity
- Trade Name
- Anti cyclic citrullinated peptide antibody (CCP) Test kit (Latex Immunoturbidimetric) EUDAMED
- Device Name
- Anti cyclic citrullinated peptide antibody (CCP) Test kit (Latex Immunoturbidimetric) EUDAMED
- Model / Reference
- R1:18mL×4 R2:6mL×4（709） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971674869894 EUDAMED
- Basic UDI-DI
- B-06971674869894 EUDAMED
- EMDN Code
- W01021112 ANTI-CYCLIC CITRULLINATED PEPTIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 (CCP) Test kit (Latex Immunoturbidim… by Biobase Biodustry(Shandong) 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-06971674869894 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Biodustry(Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025015
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED af97d59e-e5dd-4bde-8695-c9e6d7ec9e50 61 fields · synced Jun 18, 2026