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2-piece Cleaning Adapter + 4-piece Valve Kit
EUDAMEDClass IIa (EU MDR)
Ref 101070Ref 101092Ref 101050
Identity
- Trade Name
- 2-piece Cleaning Adapter + 4-piece Valve Kit EUDAMED4-piece Valve Kit EUDAMED
- Device Name
- 2-piece Cleaning Adapter + 4-piece Valve Kit EUDAMED4-piece Valve Kit EUDAMED
- Model / Reference
- 101070 EUDAMED101092 EUDAMED101050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106957958 EUDAMED04897106958627 EUDAMED04897106957897 EUDAMED
- Basic UDI-DI
- 489710695GAR3875465G EUDAMED489710695GAR046FS EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
2-piece Cleaning Adapter + 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 | 489710695GAR3875465G | 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 (4)
- EUDAMED 1697cd1e-b2c2-4ac9-9713-6a3dc1bc7e02 61 fields · synced Sep 18, 2026
- EUDAMED a48d4037-44de-491f-ba56-c1f18093d16e 61 fields · synced May 17, 2026
- EUDAMED 0ca0d3c7-2716-4eb0-bbbd-958a557d4c9c 61 fields · synced May 18, 2026
- EUDAMED 8a52def5-8aa3-4a49-8016-df0316bdc046 61 fields · synced Jul 18, 2026