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Sharay Anti-Neuronal Antibody Profile IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18188001 Model Model 5: Sharay Anti-CV2 IgG, 100 Tests/kitRef 18185001 Model Model 2: Sharay Anti-Ri IgG, 100 Tests/kitRef 18187001 Model Model 4: Sharay Anti-Ma2/Ta IgG, 100 Tests/kit
Identity
- Trade Name
- Sharay Anti-Neuronal Antibody Profile IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-Neuronal Antibody Profile IgG (CLIA) EUDAMED
- Model / Reference
- Model 5: Sharay Anti-CV2 IgG, 100 Tests/kit EUDAMED18188001 EUDAMEDModel 2: Sharay Anti-Ri IgG, 100 Tests/kit EUDAMED18185001 EUDAMEDModel 4: Sharay Anti-Ma2/Ta IgG, 100 Tests/kit EUDAMED18187001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761790 EUDAMED06975070761769 EUDAMED06975070761783 EUDAMED
- Basic UDI-DI
- B-06975070761790 EUDAMEDB-06975070761769 EUDAMEDB-06975070761783 EUDAMED
- EMDN Code
- W0102100299 NEURO-AUTO-IMMUNE DISEASE - OTHER EUDAMEDW0102100211 ANTI-RI ANTIBODY 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-Neuronal Antibody Profile 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-06975070761790 | 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 (6)
- EUDAMED 4b67d53c-10ab-4a51-ac1f-8e9d17f1fa63 61 fields · synced Jul 12, 2026
- EUDAMED c8bc8269-6204-452d-8a36-a3361019a9d5 61 fields · synced May 18, 2026
- EUDAMED e825b95c-2e99-4150-b588-b63f7753b2a5 61 fields · synced May 18, 2026
- EUDAMED c96848b0-3ca1-4d2f-88e3-38b96466e073 61 fields · synced Jul 9, 2026
- EUDAMED 102c3f85-973b-4b86-9e9b-5b558c26c329 61 fields · synced Jul 10, 2026
- EUDAMED 1185d925-4038-4af6-b0e5-483119a10b07 61 fields · synced Jul 12, 2026