Identity
- Trade Name
- Endoscopic Cold Light Source EUDAMED
- Device Name
- Endoscopic Cold Light Source EUDAMED
- Model / Reference
- ELL-200M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975043220507 EUDAMED
- Basic UDI-DI
- 697504322ELL4KEQ EUDAMED
- Direct Marketing DI
- 06975043220507 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 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 | 697504322ELL4KEQ | 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 (1)
- EUDAMED 77d334e0-5cad-4762-a958-c7fc5b52b73e 61 fields · synced Sep 30, 2026