Identity
- Device Name
- LED Light Source EUDAMED
- Model / Reference
- 400LED-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907595122498 EUDAMED
- Basic UDI-DI
- 5907595122LV-400LEDYD EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
LED Light Source by Vimex Sp. z o.o. — 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 | 5907595122LV-400LEDYD | Class I | Active |
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Manufacturer
- Manufacturer
- Vimex Sp. z o.o.
- EUDAMED SRN
- PL-MF-000008668
Sources (1)
- EUDAMED db5dd539-2f25-40ac-a7c1-1cf405b1470d 61 fields · synced Jul 10, 2026