← Back to catalogue
Sharay Anti-Ro52 IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18110001 Ref 14000727
Identity
- Trade Name
- Sharay Anti-Ro52 IgG (CLIA) EUDAMED
- Device Name
- Sharay Anti-Ro52 IgG (CLIA) EUDAMED
- Model / Reference
- 18110001 EUDAMED14000727 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070761325 EUDAMED06975070769383 EUDAMED
- Basic UDI-DI
- B-06975070761325 EUDAMEDB-06975070769383 EUDAMED
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER 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-Ro52 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-06975070761325 | 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 (3)
- EUDAMED fca205ea-6a6f-4119-9f74-4eb275f56970 61 fields · synced Jul 26, 2026
- EUDAMED b6702c7f-a188-4f49-9a95-9f20dc6a29ee 61 fields · synced Jul 23, 2026
- EUDAMED 121025f1-7a5c-418a-9df6-62df39803bba 61 fields · synced Jul 26, 2026