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Lower Gastrointestinal Video Endoscope
EUDAMEDClass IIa (EU MDR)
Ref EC-201LModel EC-200
Identity
- Trade Name
- Lower Gastrointestinal Video Endoscope EUDAMED
- Device Name
- Lower Gastrointestinal Video Endoscope EUDAMED
- Model / Reference
- EC-200 EUDAMEDEC-201L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429028669 EUDAMED
- Basic UDI-DI
- 69454290VE002PN EUDAMED
- Direct Marketing DI
- 06945429028669 EUDAMED
- EMDN Code
- Z12020606 VIDEO COLONOSCOPES 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
Lower 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 | 69454290VE002PN | 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 (1)
- EUDAMED af8b1197-658f-41ac-bfd3-4a3845ff40b8 61 fields · synced Jun 19, 2026