Identity
- Trade Name
- LED light source EUDAMED
- Device Name
- LED light source EUDAMED
- Model / Reference
- IS20000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949567040019 EUDAMED
- Basic UDI-DI
- 694956700003MA EUDAMED
- Direct Marketing DI
- 06949567040019 EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
LED light source by Guangdong Softlink Medical Innovation 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 | 694956700003MA | Class I | Active |
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Manufacturer
- Manufacturer
- Guangdong Softlink Medical Innovation Co., Ltd.
- EUDAMED SRN
- CN-MF-000025833
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED a837ca7b-0365-4578-8c03-0c4809630f59 61 fields · synced Jun 19, 2026