Identity
- Trade Name
- Mobile Surgical Light EUDAMED
- Device Name
- Mobile Surgical Light EUDAMED
- Model / Reference
- L6-AM EUDAMEDL5-AM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429023572 EUDAMED
- Basic UDI-DI
- 69454290SL002Q6 EUDAMED
- Direct Marketing DI
- 06945429023572 EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I 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
Mobile Surgical Light by Shenzhen Comen Medical Instruments Co., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69454290SL002Q6 | Class I | 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 98d6995a-08e7-475e-9cdd-b7641c380ae4 61 fields · synced Jun 19, 2026