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Medical Endoscopic Light Source
EUDAMEDClass IIa (EU MDR)
Ref ELS-2000UModel ELS-2000C
Identity
- Trade Name
- Medical Endoscopic Light Source EUDAMED
- Device Name
- Medical Endoscopic Light Source EUDAMED
- Model / Reference
- ELS-2000C EUDAMEDELS-2000U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429028744 EUDAMED
- Basic UDI-DI
- 69454290VE004PS EUDAMED
- Direct Marketing DI
- 06945429028744 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Medical Endoscopic Light Source by Shenzhen Comen Medical Instruments Co., LTD. — Class IIa — 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 | 69454290VE004PS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9adcbbc7-b2b9-4405-953d-cf107e283d38 61 fields · synced Jun 18, 2026