Identity
- Trade Name
- Medical Endoscopic Video Processor EUDAMED
- Device Name
- Medical Endoscopic Video Processor EUDAMED
- Model / Reference
- EIS-1500U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429062533 EUDAMED
- Basic UDI-DI
- 69454290VE015PX EUDAMED
- Direct Marketing DI
- 06945429062533 EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Medical Endoscopic Video Processor 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 | 69454290VE015PX | 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 4b51ee2c-08a7-41f8-b4d9-51a19ad3afbc 61 fields · synced Jun 19, 2026