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Envolite
EUDAMEDClass I (EU MDR)
Ref LF90386/SCLA180Model LF90325/TCLA300Ref LF90323/SCLA300Ref LF90324/SCLB300Ref LF90390/IRLA180Ref LF90385/IRLA300
Identity
- Trade Name
- ENVOLITE EUDAMED
- Device Name
- LED Light Source EUDAMED
- Model / Reference
- LF90325/TCLA300 EUDAMEDLF90386/SCLA180 EUDAMEDLF90323/SCLA300 EUDAMEDLF90324/SCLB300 EUDAMEDLF90390/IRLA180 EUDAMEDLF90385/IRLA300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906164080754 EUDAMED08906164080709 EUDAMED08906164080716 EUDAMED08906164080778 EUDAMED08906164080747 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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Also classified as Endoscopic light source unit, line-powered.
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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 (5)
- EUDAMED e74af1d8-e006-405d-85c7-f430b6e45169 61 fields · synced Aug 2, 2026
- EUDAMED 37b902a9-bf22-4ec4-b5ac-f0cb94c8b3e4 61 fields · synced May 17, 2026
- EUDAMED b07254ed-68c5-42ef-b66a-f853dfce734f 61 fields · synced May 17, 2026
- EUDAMED 55b64233-f502-4666-ad8c-07787ae186f3 61 fields · synced May 18, 2026
- EUDAMED dd274a95-6227-4c20-a96c-f246fb71e4a7 61 fields · synced May 18, 2026