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Light source
EUDAMEDClass IIa (EU MDR)
Ref 71-182-30 NIRModel OPTO-LED2100,71-180-30 NIR
Identity
- Trade Name
- Light source EUDAMED
- Device Name
- Light source EUDAMED
- Model / Reference
- OPTO-LED2100,71-180-30 NIR EUDAMED71-182-30 NIR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973031299467 EUDAMED
- Basic UDI-DI
- 697303129LED00001CY 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
Yes
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
Light source by Guangdong Optomedic Technologies, Inc. — 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 | 697303129LED00001CY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
- EUDAMED SRN
- CN-MF-000011588
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 2e1b13f2-1fb3-4139-8a14-e194033abebe 61 fields · synced Jun 19, 2026