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4K Endoscope Fluorescence Camera System
EUDAMEDClass I (EU MDR)
Ref SKS-FU61Model S91-4K
Identity
- Trade Name
- 4K Endoscope Fluorescence Camera System EUDAMED
- Device Name
- 4K Endoscope Fluorescence Camera System EUDAMED
- Model / Reference
- S91-4K EUDAMEDSKS-FU61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978385970369 EUDAMED
- Basic UDI-DI
- 697838597S91-4K00000000KW EUDAMED
- Direct Marketing DI
- 06978385970369 EUDAMED
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 Endoscope Fluorescence Camera System by XuZhou SYKERS Photoelectric 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 | 697838597S91-4K00000000KW | Class I | Active |
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Manufacturer
- Manufacturer
- XuZhou SYKERS Photoelectric Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000046799
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 8e9b34a3-ff87-4c70-bb1f-e4b8196a2ba7 61 fields · synced Jun 19, 2026