Identity
- Trade Name
- Medical Examination Light EUDAMED
- Device Name
- Medical Examination Light EUDAMED
- Model / Reference
- BL10A EUDAMEDBL10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429060430 EUDAMED06945429060423 EUDAMED
- Basic UDI-DI
- 69454290ME001LH EUDAMED
- Direct Marketing DI
- 06945429060430 EUDAMED06945429060423 EUDAMED
- EMDN Code
- Z11039009 FLUOROSCOPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Medical Examination 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 | 69454290ME001LH | 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 (2)
- EUDAMED 73e7d93a-df1e-4e02-bb5c-3187499710a2 61 fields · synced Oct 6, 2026
- EUDAMED 6405302c-d8d5-43db-ab58-c163c5b17141 61 fields · synced May 16, 2026