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Endoscope Camera System
EUDAMEDClass I (EU MDR)
Ref SKS-PU02Model S21-4KRef SKS-P120Model A31-HDRef SKS-P110Ref SKS-P310Ref SKS-H21Model A11-HDRef SKS-P210Ref SKS-U11Model S10-4KRef SKS-PU10Model S31-4KRef SKS-P200Ref SKS-H11Model A10-HDRef SKS-PU20Ref SKS-PU30Ref SKS-U10
Identity
- Trade Name
- Endoscope Camera System EUDAMED
- Device Name
- Endoscope Camera System EUDAMED
- Model / Reference
- S21-4K EUDAMEDSKS-PU02 EUDAMEDA31-HD EUDAMEDSKS-P120 EUDAMEDSKS-P110 EUDAMEDSKS-P310 EUDAMEDA11-HD EUDAMEDSKS-H21 EUDAMEDSKS-P210 EUDAMEDS10-4K EUDAMEDSKS-U11 EUDAMEDS31-4K EUDAMEDSKS-PU10 EUDAMEDSKS-P200 EUDAMEDA10-HD EUDAMEDSKS-H11 EUDAMEDSKS-PU20 EUDAMEDSKS-PU30 EUDAMEDSKS-U10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978385970215 EUDAMED06978385970109 EUDAMED06978385970093 EUDAMED06978385970147 EUDAMED06978385970055 EUDAMED06978385970123 EUDAMED06978385970178 EUDAMED06978385970222 EUDAMED06978385970116 EUDAMED06978385970017 EUDAMED06978385970239 EUDAMED06978385970246 EUDAMED06978385970161 EUDAMED
- Basic UDI-DI
- 697838597S21-4K00000000AX EUDAMED697838597A31-HD00000000Y5 EUDAMED697838597A11-HD00000000VK EUDAMED697838597S10-4K000000008H EUDAMED697838597S31-4K00000000C8 EUDAMED697838597A10-HD00000000UE EUDAMED
- Direct Marketing DI
- 06978385970215 EUDAMED06978385970109 EUDAMED06978385970147 EUDAMED06978385970055 EUDAMED06978385970123 EUDAMED06978385970178 EUDAMED06978385970222 EUDAMED06978385970116 EUDAMED06978385970017 EUDAMED06978385970239 EUDAMED06978385970246 EUDAMED06978385970161 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
Endoscope 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 | 697838597S21-4K00000000AX | 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 (13)
- EUDAMED c7c33435-f352-4ba0-a214-614bef066378 61 fields · synced Oct 7, 2026
- EUDAMED 5bcb57d4-d902-43cb-b939-0cc96a1f7462 61 fields · synced May 16, 2026
- EUDAMED 77157e68-57bf-42ad-98b7-69e7d82c426c 61 fields · synced May 17, 2026
- EUDAMED 89fe3eea-8ff3-4307-877b-b5451e5ba002 61 fields · synced May 17, 2026
- EUDAMED 358d47d5-4e8b-4707-8be5-49f29ff0f2b3 61 fields · synced May 17, 2026
- EUDAMED 38368047-d485-4fd6-918c-99741798d1f3 61 fields · synced May 17, 2026
- EUDAMED 4cbb4ca4-f934-4c62-a792-0ffcd8192e56 61 fields · synced May 18, 2026
- EUDAMED 8032dbff-ca65-45c7-95c3-0965667d6456 61 fields · synced May 18, 2026
- EUDAMED ef50856c-1a8d-40a4-9961-94b625b36dcb 61 fields · synced May 18, 2026
- EUDAMED ae2169a6-89d6-4b26-ac89-d5f1ed8f3de5 61 fields · synced May 18, 2026
- EUDAMED 8de4cb02-4054-4a66-aede-c4fd00972b34 61 fields · synced May 18, 2026
- EUDAMED f5937548-f636-4a44-aae8-d32b4e874745 61 fields · synced May 18, 2026
- EUDAMED 6dd2ab29-9833-4fbe-a8fe-b6865617da1d 61 fields · synced May 18, 2026