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Envolite

by Eclipse Prism Medical Devices Private Limited 8 variants

Ref LF90390/IRLA180Model LF90325/TCLA300

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890616408LSYX Basic UDI-DI 08906164080778UDI-DIDate28 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
LED Light Source
Model / Reference
LF90325/TCLA300, LF90390/IRLA180
Primary DI / UDI-DI
08906164080778
Basic UDI-DI
890616408LSYX
EMDN Code
Z12020402 Light sources for endoscopy and minimally invasive surgery
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000032926
Authorised representative
Mars Medical DE-AR-000006312

Other devices from Eclipse Prism Medical Devices Private Limited

See all devices from Eclipse Prism Medical Devices Private Limited →

Properties

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