Identity
- Trade Name
- ENVOLITE EUDAMED
- Device Name
- LED Light Source EUDAMED
- Model / Reference
- LF90325/TCLA300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906164080723 EUDAMED
- Basic UDI-DI
- 890616408LSYX 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
Envolite by Eclipse Prism Medical Devices Private Limited — 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 | 890616408LSYX | Class I | Active |
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Manufacturer
- Manufacturer
- Eclipse Prism Medical Devices Private Limited
- EUDAMED SRN
- IN-MF-000032926
- Authorised Representative
- Mars Medical DE-AR-000006312
Sources (1)
- EUDAMED a8d28bb1-0563-4fa7-86c9-4fdda2f3bf2a 61 fields · synced Jun 19, 2026