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Sharay aCL IgA/G/M (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18133001 Model 100 Tests/kitRef 14000744
Identity
- Trade Name
- Sharay aCL IgA/G/M (CLIA) EUDAMED
- Device Name
- Sharay aCL IgA/G/M (CLIA) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED18133001 EUDAMED14000744 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761516 EUDAMED06975070769611 EUDAMED
- Basic UDI-DI
- B-06975070761516 EUDAMEDB-06975070769611 EUDAMED
- EMDN Code
- W0102100501 ANTI-CARDIOLIPIN ANTIBODIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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 aCL IgA/G/M (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-06975070761516 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035089
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (3)
- EUDAMED dca74667-c735-4a09-9bc5-c093a2774049 61 fields · synced Aug 2, 2026
- EUDAMED 1d350a8f-c6b6-4be3-ae24-def5fb410999 61 fields · synced Jul 13, 2026
- EUDAMED 493989ac-c600-4b36-aa24-8245ac258f74 61 fields · synced Aug 2, 2026