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Medical Endoscope Camera System
EUDAMEDClass I (EU MDR)
Ref 06976115161162Model NCM-FHD180
Identity
- Trade Name
- Medical Endoscope Camera System EUDAMED
- Device Name
- Medical Endoscope Camera Systems EUDAMED
- Model / Reference
- NCM-FHD180 EUDAMED06976115161162 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976115161162 EUDAMED
- Basic UDI-DI
- 697611516116J4 EUDAMED
- Direct Marketing DI
- 06976115161162 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
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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 Endoscope Camera System by Shenzhen New Concept Med. Tec. Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: 27-inch 4K All-in-one Endoscope Camera System
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 | 697611516116J4 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen New Concept Med. Tec. Co., Ltd
- EUDAMED SRN
- CN-MF-000034909
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 4bcd1c5b-e449-4325-83da-a904d24e3354 61 fields · synced Jun 19, 2026