Identity
- Trade Name
- Scope Valve Biopsy Valve EUDAMED
- Device Name
- Biopsy Valve EUDAMED
- Model / Reference
- ENDO018S EUDAMEDENDO028S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106951802 EUDAMED04897106951833 EUDAMED
- Basic UDI-DI
- 489710695GAR028-SS5 EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Scope Valve Biopsy Valve by Ga Health Company Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 489710695GAR028-SS5 | Class I | Active |
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Manufacturer
- Manufacturer
- GA Health Company Limited
- EUDAMED SRN
- HK-MF-000019784
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 7f4dc526-4189-4dc2-8354-27d4e4258080 61 fields · synced Aug 3, 2026
- EUDAMED c750f385-bcef-46d3-b292-d7bc5337781b 61 fields · synced May 18, 2026