← Back to catalogue
Sharay Anti-CCP IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18147001 Model 100 Tests/kitRef 14000738
Identity
- Trade Name
- Sharay Anti-CCP IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-CCP IgG (CLIA) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED18147001 EUDAMED14000738 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070760960 EUDAMED06975070769758 EUDAMED
- Basic UDI-DI
- B-06975070760960 EUDAMEDB-06975070769758 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMEDW01021112 ANTI-CYCLIC CITRULLINATED PEPTIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Sharay Anti-CCP IgG (CLIA) by C-Luminary Biotechnology Co., Ltd. — 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-06975070760960 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED 3e6a8ea9-cd75-4689-9346-093f38c15ef5 61 fields · synced Jul 24, 2026
- EUDAMED 67b95358-db52-4a85-9611-0e0593882244 61 fields · synced Jul 17, 2026
- EUDAMED 8074f726-5275-4366-afd1-366b181b91ae 61 fields · synced Jul 24, 2026