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4K endoscopic camera system
EUDAMEDClass I (EU MDR)
Ref VIS-60Ref VIS-60ARef VIS-50Ref VIS-50A
Identity
- Trade Name
- 4K endoscopic camera system EUDAMED
- Device Name
- 4K endoscopic camera system EUDAMED
- Model / Reference
- VIS-60 EUDAMEDVIS-60A EUDAMEDVIS-50 EUDAMEDVIS-50A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429028560 EUDAMED06945429028577 EUDAMED06945429028539 EUDAMED06945429028546 EUDAMED
- Basic UDI-DI
- 69454290ES001LT EUDAMED
- Direct Marketing DI
- 06945429028560 EUDAMED06945429028577 EUDAMED06945429028539 EUDAMED06945429028546 EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
Classification
- Device Class
- Class I 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
4K endoscopic camera system by Shenzhen Comen Medical Instruments Co., LTD. — Class I — 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 | 69454290ES001LT | Class I | 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 c2cb1fdb-0d99-4ca3-91eb-08b1b6a52a97 61 fields · synced Oct 6, 2026
- EUDAMED 6e210f71-2172-4021-a050-b41e1d51a6cb 61 fields · synced May 18, 2026
- EUDAMED 2c1cb6b6-1397-4fb3-b059-abb28334f18f 61 fields · synced May 18, 2026
- EUDAMED f33dd372-287e-4554-b8cb-707d40588d88 61 fields · synced May 19, 2026