← Back to catalogue
4K Endoscope Fluorescence Camera System
EUDAMEDClass I (EU MDR)
Ref SKS-FU21Model S71-4K
Identity
- Trade Name
- 4K Endoscope Fluorescence Camera System EUDAMED
- Device Name
- 4K Endoscope Fluorescence Camera System EUDAMED
- Model / Reference
- S71-4K EUDAMEDSKS-FU21 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978385970284 EUDAMED
- Basic UDI-DI
- 697838597S71-4K00000000HC EUDAMED
- Direct Marketing DI
- 06978385970284 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 | 697838597S71-4K00000000HC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 aef5ad3a-4890-410b-8cb6-6f9dd19ad5d3 61 fields · synced Oct 6, 2026