Identity
- Trade Name
- WOEK EUDAMED
- Device Name
- Cold Light Source EUDAMED4K Endovision Camera System EUDAMED4K Endoscopic Fluorescence Imaging System EUDAMED
- Model / Reference
- WK-L120 EUDAMEDWK-4K EUDAMEDWK-4K-YG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973096670010 EUDAMED06973096670034 EUDAMED06973096670027 EUDAMED
- Basic UDI-DI
- 697309667CLS01LS EUDAMED6973096674KECS01MD EUDAMED6973096674KEFIS012R EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMEDZ12020405 SURGICAL CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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
Category: Endoscopic light source unit, line-powered
Woek by Nanchang Woek Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697309667CLS01LS | Class I | Active |
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Manufacturer
- Manufacturer
- Nanchang Woek Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000035830
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 6596bd92-5e5d-4ca6-bfb1-d4c85bc00230 61 fields · synced Jul 19, 2026
- EUDAMED 74700c47-4dba-459f-8b19-8e6ad72e7876 61 fields · synced May 16, 2026
- EUDAMED 466f896a-0df2-4618-ae08-b14ff20c0ce3 61 fields · synced May 17, 2026