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Delon
EUDAMEDClass I (EU MDR)
Ref N/AModel LED300Model HD380
by Beijing Fanxing Guangdian Medical Treatment Equipment Co., Ltd
Identity
- Trade Name
- DELON EUDAMED
- Device Name
- Medical Endoscopic cold light source EUDAMEDMedical Endoscopic camera EUDAMED
- Model / Reference
- LED300 EUDAMEDN/A EUDAMEDHD380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975648372007 EUDAMED06975648371000 EUDAMED
- Basic UDI-DI
- 697564837LIGHTSOURCECB EUDAMED697564837CAMERASC 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
- 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
Category: Endoscopic light source unit, line-powered
Delon by Beijing Fanxing Guangdian Medical Treatment Equipment 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 | 697564837LIGHTSOURCECB | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000026984
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED f3f384c8-56f6-40b6-ae6f-cd85ce1a43d0 61 fields · synced Jul 25, 2026
- EUDAMED 7d3ef3f6-c110-41d2-9359-100c2cde6aa3 61 fields · synced May 19, 2026