Identity
- Trade Name
- Champion 3-piece valve kit EUDAMED
- Device Name
- 3-piece Valve Kit EUDAMED
- Model / Reference
- 101037 EUDAMED101065 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106957842 EUDAMED04897106957903 EUDAMED
- Basic UDI-DI
- 489710695GAR004FA 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
Category: Tissue morcellation system handpiece, line-powered
Champion 3-piece valve kit by Ga Health Company Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tissue morcellation system handpiece, line-powered.
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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 | 489710695GAR004FA | 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 b578f062-a172-4075-8ad1-82f70c57c9fd 61 fields · synced Jul 19, 2026
- EUDAMED 50510fb7-5de3-41c1-83f8-7e63ea577849 61 fields · synced May 18, 2026