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Truglow

by Appasamy Associates Private Limited 4 variants

Ref Legend Truglow FS1 - Without Camera

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number89043437VSOM/AAOMWP Basic UDI-DI 08904343742325UDI-DIDate4 Feb 2026RegisteredStatusActive

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  • Withdrawn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
Visualization System for Ophthalmic Micro Surgery
Model / Reference
Legend Truglow FS1 - Without Camera
Primary DI / UDI-DI
08904343742325
Basic UDI-DI
89043437VSOM/AAOMWP
EMDN Code
Z12011101 Operative microscopes
Device Class
Class I
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
IN-MF-000012093
Authorised representative
Amstermed B.V. NL-AR-000001971

Other devices from Appasamy Associates Private Limited

See all devices from Appasamy Associates 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