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Video Gastroscope
EUDAMEDClass IIa (EU MDR)
Ref /Model GVE-2900HT/GVE-2900HQ/GVE-2900HX/GVE-2900HS/GVE-3000HT/GVE-3000HQ/GVE-3000HP/GVE-3500HT/GVE-3500HQ/GVE-3500HP
Identity
- Device Name
- Video Gastroscope EUDAMED
- Model / Reference
- GVE-2900HT/GVE-2900HQ/GVE-2900HX/GVE-2900HS/GVE-3000HT/GVE-3000HQ/GVE-3000HP/GVE-3500HT/GVE-3500HQ/GVE-3500HP EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953393155045 EUDAMED06953393155168 EUDAMED06953393155120 EUDAMED06953393155014 EUDAMED
- Basic UDI-DI
- 69533931GAFA EUDAMED
- EMDN Code
- Z12020511 VIDEO GASTROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Video Gastroscope by HUGER Medical Instrument Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69533931GAFA | Class IIa | Active |
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Manufacturer
- Manufacturer
- HUGER Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000001128
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 431d25fa-52c4-414c-bb82-2b073685c385 61 fields · synced Oct 6, 2026
- EUDAMED 37b4f8f1-cc9d-4b3b-9df1-1e41c859d4d6 61 fields · synced May 17, 2026
- EUDAMED 2076a2ce-b3a7-4546-b53f-7e19d8ddee02 61 fields · synced May 17, 2026
- EUDAMED 1af50b00-5c73-483b-906c-08b3a6885190 61 fields · synced May 19, 2026