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Lower Gastrointestinal Video Endoscope
EUDAMEDClass IIa (EU MDR)
Ref EC-A30TModel EC-300L
Identity
- Trade Name
- Lower Gastrointestinal Video Endoscope EUDAMED
- Device Name
- Lower Gastrointestinal Video Endoscope EUDAMED
- Model / Reference
- EC-300L EUDAMEDEC-A30T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429060409 EUDAMED
- Basic UDI-DI
- 69454290LG001LL EUDAMED
- Direct Marketing DI
- 06945429060409 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 | 69454290LG001LL | 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 3cb38a0f-0c4f-4087-9f7b-cce3d9b2aec2 61 fields · synced Jun 18, 2026