Identity
- Trade Name
- ENVOLITE EUDAMED
- Device Name
- LED Light Source EUDAMED
- Model / Reference
- LF90325/TCLA300 EUDAMEDLF90388/TCLA180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906164080761 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
Envolite by Eclipse Prism Medical Devices Private Limited — 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 | 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 75c31205-7e85-417a-8484-3600dfe5eb16 61 fields · synced Jun 19, 2026