← Back to catalogue
Sharay Anti-Myositis Antibody Profile IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18178001Model Model 12: Sharay Anti-SRP IgG,100 Tests/kit
Identity
- Trade Name
- Sharay Anti-Myositis Antibody Profile IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-Myositis Antibody Profile IgG (CLIA) EUDAMED
- Model / Reference
- Model 12: Sharay Anti-SRP IgG,100 Tests/kit EUDAMED18178001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761653 EUDAMED
- Basic UDI-DI
- B-06975070761653 EUDAMED
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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-Myositis 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-06975070761653 | 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 (1)
- EUDAMED 9b235c2c-b2b5-4a1a-bf14-1adfe94f2a70 61 fields · synced Oct 5, 2026