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LightWalker AT

by FOTONA, proizvodnja optoelektronskih naprav d.o.o.

Ref M021-5AF/1

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3830054230004S7 Basic UDI-DI 03830054230194UDI-DIDate13 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number03830054230194 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
General/multiple surgical solid-state laser system
Device Name
LightWalker/TimeWalker
Model / Reference
M021-5AF/1
Primary DI / UDI-DI
03830054230194
Basic UDI-DI
3830054230004S7
FDA Product Code
PDZ, GEX, NVK, ILY
EMDN Code
Z12011019 Multi–platform laser
GMDN Term
General/multiple surgical solid-state laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810, 890.5500
EU market of registration
Poland
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
SI-MF-000000126

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Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No