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Sharay Anti-Intestinal Goblet Cell IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18161001 Model 100 Tests/kitRef 18161002
Identity
- Trade Name
- Sharay Anti-Intestinal Goblet Cell IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-Intestinal Goblet Cell IgG (CLIA) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED18161001 EUDAMED18161002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761486 EUDAMED06975070767747 EUDAMED
- Basic UDI-DI
- B-06975070761486 EUDAMEDB-06975070767747 EUDAMED
- EMDN Code
- W0102109099 AUTO-IMMUNE DISEASE TESTS - OTHER EUDAMEDW0102100899 OTHERS INFLAMATORY BOWEL DISEASE 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 Anti-Intestinal Goblet Cell IgG (CLIA) by C-Luminary Biotechnology Co., Ltd. — 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-06975070761486 | 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 80f8bf82-a7e1-4190-a4ca-03cbe486554d 61 fields · synced Oct 5, 2026
- EUDAMED 7f4c045b-63ea-459c-9c39-081bd5bebbbb 61 fields · synced Jul 12, 2026
- EUDAMED 90956ee3-a174-4bc4-a77c-93eb5d94e077 61 fields · synced Oct 5, 2026