Identity
- Device Name
- Light Source EUDAMED
- Model / Reference
- UNT-LED300 EUDAMEDUNT-LED200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260706010086 EUDAMED04260706010079 EUDAMED
- Basic UDI-DI
- 426070601031LSK8 EUDAMED
- Direct Marketing DI
- 04260706010086 EUDAMED04260706010079 EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY 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
Category: Endoscopic light source unit, line-powered
Light Source by Unintech GmbH — Class I — 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 | 426070601031LSK8 | Class I | Active |
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Manufacturer
- Manufacturer
- Unintech GmbH
- EUDAMED SRN
- DE-MF-000005136
Sources (2)
- EUDAMED f31f59d9-3e1c-42ee-b792-3db37396a5c3 61 fields · synced Sep 17, 2026
- EUDAMED 0a29a410-633d-4a0a-9b59-7062515e523f 61 fields · synced May 17, 2026