Identity
- Trade Name
- Endoscope Camera System EUDAMED
- Device Name
- Endoscope Camera System EUDAMED
- Model / Reference
- A21-HD EUDAMEDSKS-PH01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978385970062 EUDAMED
- Basic UDI-DI
- 697838597A21-HD00000000WU EUDAMED
- Direct Marketing DI
- 06978385970062 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 | 697838597A21-HD00000000WU | 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 008bfad9-9e6a-40a1-9400-d3116b81e879 61 fields · synced Oct 5, 2026