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4K Endoscope Fluorescence Camera System
EUDAMEDClass I (EU MDR)
Ref SKS-FU31Model S80-4KRef SKS-FU51Model S90-4KRef SKS-FU40Model S81-4KRef SKS-FU41Ref SKS-FU60Model S91-4K Ref SKS-FU30Ref SKS-FU10Model S70-4KRef SKS-FU20Model S71-4KRef SKS-FU11
Identity
- Trade Name
- 4K Endoscope Fluorescence Camera System EUDAMED
- Device Name
- 4K Endoscope Fluorescence Camera System EUDAMED
- Model / Reference
- S80-4K EUDAMEDSKS-FU31 EUDAMEDS90-4K EUDAMEDSKS-FU51 EUDAMEDS81-4K EUDAMEDSKS-FU40 EUDAMEDSKS-FU41 EUDAMEDS91-4K EUDAMEDSKS-FU60 EUDAMEDSKS-FU30 EUDAMEDS70-4K EUDAMEDSKS-FU10 EUDAMEDS71-4K EUDAMEDSKS-FU20 EUDAMEDSKS-FU11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978385970307 EUDAMED06978385970345 EUDAMED06978385970314 EUDAMED06978385970321 EUDAMED06978385970352 EUDAMED06978385970291 EUDAMED06978385970253 EUDAMED06978385970277 EUDAMED06978385970260 EUDAMED
- Basic UDI-DI
- 697838597S80-4K00000000HG EUDAMED697838597S90-4K00000000JR EUDAMED697838597S81-4K00000000JM EUDAMED697838597S91-4K00000000KW EUDAMED697838597S70-4K00000000G7 EUDAMED697838597S71-4K00000000HC EUDAMED
- Direct Marketing DI
- 06978385970307 EUDAMED06978385970345 EUDAMED06978385970314 EUDAMED06978385970321 EUDAMED06978385970352 EUDAMED06978385970291 EUDAMED06978385970253 EUDAMED06978385970277 EUDAMED06978385970260 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 | 697838597S80-4K00000000HG | 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 (9)
- EUDAMED bd3cff84-cad2-425c-8633-f7d8f430e360 61 fields · synced Oct 6, 2026
- EUDAMED 16b3a61f-2c07-48f7-9f25-a16599afc335 61 fields · synced May 11, 2026
- EUDAMED bb7a1383-b67c-4e73-9d21-beccf15410d4 61 fields · synced May 17, 2026
- EUDAMED d173893d-482d-4196-aee5-0da16e4e1aaa 61 fields · synced May 18, 2026
- EUDAMED 9d1c6c69-bc8d-4140-8936-fcc9c4180170 61 fields · synced May 18, 2026
- EUDAMED ebc893af-afe7-41dc-9389-f12d4bb24175 61 fields · synced May 18, 2026
- EUDAMED 2816931e-5822-4111-9ab1-7bb20dddf8ef 61 fields · synced May 18, 2026
- EUDAMED 90dae24f-7010-4ca5-8362-46a7f47e8809 61 fields · synced May 18, 2026
- EUDAMED 9365fa37-ab94-40c0-aa72-fcdaf57a95d3 61 fields · synced May 19, 2026