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Upper Gastrointestinal Video Endoscope
EUDAMEDClass IIa (EU MDR)
Ref EG-200Ref EG-200T
Identity
- Trade Name
- Upper Gastrointestinal Video Endoscope EUDAMED
- Device Name
- Upper Gastrointestinal Video Endoscope EUDAMED
- Model / Reference
- EG-200 EUDAMEDEG-200T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429028591 EUDAMED06945429028607 EUDAMED
- Basic UDI-DI
- 69454290VE001PL EUDAMED
- Direct Marketing DI
- 06945429028591 EUDAMED06945429028607 EUDAMED
- EMDN Code
- Z12020510 VIDEO GASTRODUODENOSCOPES 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
Upper Gastrointestinal Video Endoscope by Shenzhen Comen Medical Instruments 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 | 69454290VE001PL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 6af99721-fb61-4662-a507-158be2ac3e3c 61 fields · synced Oct 6, 2026
- EUDAMED 3b87bc4f-be1e-468e-9155-eab3605464a8 61 fields · synced May 18, 2026