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Flexible Video Gastroscopes
EUDAMEDClass IIa (EU MDR)
Ref Smart GN-600EAModel Smart GT-600BA
Identity
- Device Name
- Flexible Video Gastroscopes EUDAMED
- Model / Reference
- Smart GT-600BA EUDAMEDSmart GN-600EA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973592350041 EUDAMED
- Basic UDI-DI
- 697359235P05SC EUDAMED
- Direct Marketing DI
- 06973592350041 EUDAMED
- EMDN Code
- Z12020506 GASTROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Flexible Video Gastroscopes by Beijing LepuImage Technology 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 | 697359235P05SC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing LepuImage Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000026645
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e28674b4-babc-413b-bce7-667ed5bec134 61 fields · synced Oct 6, 2026