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VACUTORE CO2 adapter for Fujifilm Insufflator GW-100
EUDAMEDClass IIa (EU MDR)
Ref ENDO108
Identity
- Trade Name
- VACUTORE CO2 adapter for Fujifilm Insufflator GW-100 EUDAMED
- Device Name
- VACUTORE CO2 adapter EUDAMED
- Model / Reference
- ENDO108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897106957064 EUDAMED
- Basic UDI-DI
- 489710695GAR093G3 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
VACUTORE CO2 adapter for Fujifilm Insufflator GW-100 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 | 489710695GAR093G3 | 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 6d68864a-c128-4e93-9978-e11efb6c1112 61 fields · synced Jun 19, 2026