Identity
- Trade Name
- Sharay hs-cTnI (CLIA) EUDAMED
- Device Name
- Sharay hs-cTnI (CLIA) EUDAMED
- Model / Reference
- 18305101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070762476 EUDAMED
- Basic UDI-DI
- B-06975070762476 EUDAMED
- EMDN Code
- W01021306 TROPONIN I/T 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 hs-cTnI (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-06975070762476 | 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 (2)
- EUDAMED 6548cb51-dd0e-412a-b9a5-b228c5db8f48 61 fields · synced Jun 19, 2026
- EUDAMED 77c7e16b-862a-4df0-8136-cdb45ac8ecd3 61 fields · synced Jun 19, 2026