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Champion 4-piece valve kit
EUDAMEDClass IIa (EU MDR)
Ref 101046Ref 101081Ref 101092Ref 101004CRef 101037C
Identity
- Trade Name
- Champion 4-piece valve kit EUDAMEDChampion 2-piece valve kit EUDAMED
- Device Name
- 4-piece Valve Kit EUDAMED2-piece Valve Kit EUDAMED
- Model / Reference
- 101046 EUDAMED101081 EUDAMED101092 EUDAMED101004C EUDAMED101037C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106957859 EUDAMED04897106957965 EUDAMED04897106957989 EUDAMED04897106955602 EUDAMED04897106955633 EUDAMED
- Basic UDI-DI
- 489710695GAR046FS EUDAMED489710695GAR004CKY EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass 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 4-piece valve kit by Ga Health Company Limited — Class IIa — 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 | 489710695GAR046FS | Class IIa | 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 (5)
- EUDAMED 552323e2-ea98-4f8a-a140-f28de7eba49a 61 fields · synced Jul 25, 2026
- EUDAMED 21804687-8b5a-4d3a-aac6-4798abecf196 61 fields · synced May 18, 2026
- EUDAMED 69c27f58-27b7-4dda-a341-7d32ef72ad11 61 fields · synced May 18, 2026
- EUDAMED 2fcfdf51-211b-4c4e-be05-6748a7db0ac0 61 fields · synced Jul 9, 2026
- EUDAMED 7d7dc91b-c96b-4957-9ac7-ed06318cb7f3 61 fields · synced Jul 9, 2026