Identity
- Trade Name
- Sharay G17 (CLIA) EUDAMED
- Device Name
- Sharay G17 (CLIA) EUDAMED
- Model / Reference
- 18917001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070763138 EUDAMED
- Basic UDI-DI
- B-06975070763138 EUDAMED
- EMDN Code
- W0102069001 GASTRIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Explore the Sharay G17 (CLIA) medical device with its detailed specifications, including sterilization status, reagent usage, and compliance information.
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-06975070763138 | 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 60b8d2b2-f642-4a19-9c8a-bd2455485bb5 61 fields · synced Jul 16, 2026
- EUDAMED 1f8e8a50-c1c0-4c80-ae15-ef0ff9304554 61 fields · synced Jun 20, 2026