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Fluorescent endoscope cold light source
EUDAMEDClass I (EU MDR)
Ref HORUS LED -4200
Identity
- Trade Name
- Fluorescent endoscope cold light source EUDAMED
- Device Name
- Fluorescent endoscope cold light source EUDAMED
- Model / Reference
- HORUS LED -4200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976982090906 EUDAMED
- Basic UDI-DI
- 697698209FECLSTY EUDAMED
- Direct Marketing DI
- 16976982090906 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Fluorescent endoscope cold light source by Shinevia (Shandong) 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 | 697698209FECLSTY | Class I | Active |
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Manufacturer
- Manufacturer
- Shinevia (Shandong) Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000049465
- Authorised Representative
- Everbiz GmbH DE-AR-000008964
Sources (1)
- EUDAMED be7e77ed-66e1-4747-9e6d-90e0e3830011 61 fields · synced Jul 26, 2026