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Endoscopic LED Cold Light Source
EUDAMEDClass I (EU MDR)
Ref ELL-080A; ELL-080B; ELL-080C
Identity
- Trade Name
- Endoscopic LED Cold Light Source EUDAMED
- Device Name
- Endoscopic LED Cold Light Source EUDAMED
- Model / Reference
- ELL-080A; ELL-080B; ELL-080C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975043220279 EUDAMED
- Basic UDI-DI
- 697504322ELL00CQ EUDAMED
- Direct Marketing DI
- 06975043220279 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
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
Endoscopic LED Cold Light Source by Zhejiang Healnoc 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 | 697504322ELL00CQ | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Healnoc Technology CO., LTD
- EUDAMED SRN
- CN-MF-000032512
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED c74506f1-685a-403e-909a-7975947acf41 61 fields · synced Jul 9, 2026
- EUDAMED c74506f1-685a-403e-909a-7975947acf41-1 61 fields · synced Jun 10, 2026