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Sharay Anti-RA33 IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18148001 Model 100 Tests/kitRef 14000772
Identity
- Trade Name
- Sharay Anti-RA33 IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-RA33 IgG (CLIA) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED18148001 EUDAMED14000772 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761943 EUDAMED06975070769765 EUDAMED
- Basic UDI-DI
- B-06975070761943 EUDAMEDB-06975070769765 EUDAMED
- EMDN Code
- W01021110 RHEUMATOID FACTORS EUDAMEDW01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER 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-RA33 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-06975070761943 | 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 60e0d1fd-ef63-4b1c-a971-e7ec8936d057 61 fields · synced Aug 1, 2026
- EUDAMED 3cd5fcc6-6cd2-4e72-9f0f-023f069567b7 61 fields · synced Jul 24, 2026
- EUDAMED cd648fe0-8357-4181-9e49-814d0cc41ce6 61 fields · synced Aug 1, 2026