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Medical Endoscopic Video Processor
EUDAMEDClass IIa (EU MDR)
Ref EIS-1500ProModel EIS-1500URef EIS-2000SModel EIS-2000URef EIS-2000CRef EIS-1000EModel EIS-1000U
Identity
- Trade Name
- Medical Endoscopic Video Processor EUDAMED
- Device Name
- Medical Endoscopic Video Processor EUDAMED
- Model / Reference
- EIS-1500U EUDAMEDEIS-1500Pro EUDAMEDEIS-2000U EUDAMEDEIS-2000S EUDAMEDEIS-2000C EUDAMEDEIS-1000U EUDAMEDEIS-1000E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429062540 EUDAMED06945429028713 EUDAMED06945429028690 EUDAMED06945429062625 EUDAMED
- Basic UDI-DI
- 69454290VE015PX EUDAMED69454290VE003PQ EUDAMED69454290VE012PR EUDAMED
- Direct Marketing DI
- 06945429062540 EUDAMED06945429028713 EUDAMED06945429028690 EUDAMED06945429062625 EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMEDIreland 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 (4)
- EUDAMED 27c5f767-3771-4183-be24-d36b29420e1a 61 fields · synced Oct 6, 2026
- EUDAMED 9d9002b6-c429-406f-859b-a8e99f921176 61 fields · synced May 18, 2026
- EUDAMED 6b4d9408-ceaa-4bcf-bb95-d7404ce9e05a 61 fields · synced May 19, 2026
- EUDAMED 11af1bec-10f5-47e9-853e-eb8099c2ed99 61 fields · synced May 19, 2026