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Fluorescent endoscope cold light source
EUDAMEDClass I (EU MDR)
Ref HORUS LED -4100
Identity
- Trade Name
- Fluorescent endoscope cold light source EUDAMED
- Device Name
- Fluorescent endoscope cold light source EUDAMED
- Model / Reference
- HORUS LED -4100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16976982090890 EUDAMED
- Basic UDI-DI
- 697698209FECLSTY EUDAMED
- Direct Marketing DI
- 16976982090890 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
Category: Endoscopic light source unit, line-powered
Fluorescent endoscope cold light source by Shinevia (Shandong) 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 | 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 62d8ad8b-8fb1-48a4-b9b6-0e43378ad505 61 fields · synced Jun 18, 2026