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4K UHD Camera System
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref EL-4K82/82CModel EL-4K81/82C, EL-4K82/82CRef ES-CS4K100/200CModel ES-CS4K100/100C,ES-CS4K100/200C,ES-CS4K200/200C,ES-CS4K200/100CRef ES-CS4K200/200C
Identity
- Trade Name
- 4K UHD Camera System EUDAMED
- Device Name
- 4K UHD Camera System EUDAMED
- Model / Reference
- EL-4K81/82C, EL-4K82/82C EUDAMEDEL-4K82/82C EUDAMEDES-CS4K100/100C,ES-CS4K100/200C,ES-CS4K200/200C,ES-CS4K200/100C EUDAMEDES-CS4K100/200C EUDAMEDES-CS4K200/200C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971381252323 EUDAMED06971381250077 EUDAMED06971381250084 EUDAMED
- Basic UDI-DI
- 697138125026A8Q EUDAMED697138125002A82 EUDAMED
- Direct Marketing DI
- 06971381250077 EUDAMED06971381250084 EUDAMED
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMEDGermany 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200216 | Class I | Active |
| 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 (4)
- EUDAMED 1689dda6-8104-4893-9577-7ffbefe49fa8 61 fields · synced Jul 29, 2026
- EUDAMED 8447174c-e18b-424a-9723-43ffde573d20 61 fields · synced May 17, 2026
- EUDAMED d3d8ccb7-54ee-4e0d-a1e7-990de8fe6978 61 fields · synced May 18, 2026
- FDA 510(k) K200216 1 fields · synced May 18, 2026