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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
- 06953393155151 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 Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69533931GAFA | Class IIa | Unknown |
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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 (1)
- EUDAMED 9275cbfd-94f1-4cca-92e0-b253ae26b132 61 fields · synced Jun 18, 2026