Envolite
by Eclipse Prism Medical Devices Private Limited India EUDAMED
Ref LF90324/SCLB300Model LF90325/TCLA300
EMDN Z12020402
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number890616408LSYX | Date28 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- LED Light Source
- Model / Reference
- LF90325/TCLA300, LF90324/SCLB300
- Primary DI / UDI-DI
- 08906164080716
- Basic UDI-DI
- 890616408LSYX
- EMDN Code
- Z12020402 Light sources for endoscopy and minimally invasive surgery
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000032926
- Authorised representative
- Mars Medical DE-AR-000006312
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED b07254ed-68c5-42ef-b66a-f853dfce734f