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2-piece Cleaning Adapter + 4-piece Valve Kit
EUDAMEDClass IIa (EU MDR)
Ref 101096
Identity
- Trade Name
- 2-piece Cleaning Adapter + 4-piece Valve Kit EUDAMED
- Device Name
- 2-piece Cleaning Adapter + 4-piece Valve Kit EUDAMED
- Model / Reference
- 101096 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106958023 EUDAMED
- Basic UDI-DI
- 489710695GAR3875465G 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
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
2-piece Cleaning Adapter + 4-piece Valve Kit by Ga Health Company Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system handpiece, line-powered.
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- NICO Myriad — NICO Corporation · Class II
- OverStitch™ — Boston Scientific · Class IIa
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 (1)
- EUDAMED 90abad93-2c52-4df0-a3f5-b6fc7722556e 61 fields · synced May 29, 2026