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4K UHD Camera System
EUDAMEDClass I (EU MDR)
Ref EL-4K81/82CModel EL-4K81/82C, EL-4K82/82C
Identity
- Trade Name
- 4K UHD Camera System EUDAMED
- Device Name
- 4K UHD Camera System EUDAMED
- Model / Reference
- EL-4K81/82C, EL-4K82/82C EUDAMEDEL-4K81/82C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381252293 EUDAMED
- Basic UDI-DI
- 697138125026A8Q EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
4K UHD Camera System by Scivita Medical Technology 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 | 697138125026A8Q | Class I | Active |
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Manufacturer
- Manufacturer
- Scivita Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010305
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8cd8835a-a047-4f5f-b9eb-2c1d076ba0d1 61 fields · synced Jun 19, 2026