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Medical Endoscopic LED Cold Light Source
EUDAMEDClass I (EU MDR)
Ref wMizar 10uModel wMizar 10u、wMizar 10p、wMizar 10a、wMizar 10c、wMizar V10A、wMizar V10B、wMizar V10C、 wMizar V10D、wMizar V10E、wMizar V10F
Identity
- Trade Name
- Medical Endoscopic LED Cold Light Source EUDAMED
- Device Name
- Medical Endoscopic LED Cold Light Source EUDAMED
- Model / Reference
- wMizar 10u、wMizar 10p、wMizar 10a、wMizar 10c、wMizar V10A、wMizar V10B、wMizar V10C、 wMizar V10D、wMizar V10E、wMizar V10F EUDAMEDwMizar 10u EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975621670090 EUDAMED
- Basic UDI-DI
- 697562167Z12020402018C EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Endoscopic light source unit, line-powered
Medical Endoscopic LED Cold Light Source by Weyo Surgical Technology Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Endoscopic light source unit, line-powered.
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- SL-ED10 — SONOSCAPE MEDICAL CORP. · Class I
- FUJIFILM — FUJIFILM Corporation · Class II
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 | 697562167Z12020402018C | Class I | Active |
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Manufacturer
- Manufacturer
- Weyo Surgical Technology Ltd.
- EUDAMED SRN
- CN-MF-000038773
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e418324a-cd30-445d-b321-932e4215d367 61 fields · synced Jun 18, 2026