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Medical Endoscopic Light Source
EUDAMEDClass IIa (EU MDR)
Ref ELS-2010CModel ELS-2000CRef LS-60BModel LS-60CRef LS-60Ref LS-60ARef ELS-1500CModel ELS-1500U
Identity
- Trade Name
- Medical Endoscopic Light Source EUDAMED
- Device Name
- Medical Endoscopic Light Source EUDAMED
- Model / Reference
- ELS-2000C EUDAMEDELS-2010C EUDAMEDLS-60C EUDAMEDLS-60B EUDAMEDLS-60 EUDAMEDLS-60A EUDAMEDELS-1500U EUDAMEDELS-1500C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429028751 EUDAMED06945429028515 EUDAMED06945429025996 EUDAMED06945429028508 EUDAMED06945429062588 EUDAMED
- Basic UDI-DI
- 69454290VE004PS EUDAMED69454290WS002T3 EUDAMED69454290VE014PV EUDAMED
- Direct Marketing DI
- 06945429028751 EUDAMED06945429028515 EUDAMED06945429025996 EUDAMED06945429028508 EUDAMED06945429062588 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Ireland EUDAMEDFinland 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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Also classified as Endoscopic light source unit, line-powered.
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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 (5)
- EUDAMED b6c9610f-18e1-49db-9e60-d2f732ac42e0 61 fields · synced Jul 24, 2026
- EUDAMED 64f1c57d-d037-4de8-91dc-370f3d6f8d5f 61 fields · synced May 18, 2026
- EUDAMED 2f791dbb-8671-4cd7-ab5d-59094b94b99c 61 fields · synced May 18, 2026
- EUDAMED 52b1a91c-3be5-4e8d-95e1-a06bc142a3c6 61 fields · synced May 19, 2026
- EUDAMED b8c641da-21c1-471c-a8f5-519463a02dfa 61 fields · synced May 19, 2026