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Sharay ENA Screen IgG (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 18155001Model 100 Tests/kit
Identity
- Trade Name
- Sharay ENA Screen IgG (CLIA) EUDAMED
- Device Name
- Sharay ENA Screen IgG (CLIA) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED18155001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070765385 EUDAMED
- Basic UDI-DI
- B-06975070765385 EUDAMED
- EMDN Code
- W0102100102 ENA SCREENING EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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 ENA Screen 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-06975070765385 | 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 (1)
- EUDAMED 688c70e0-98e1-4844-9d02-5d3693dd1b50 61 fields · synced Jul 12, 2026