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VisuMax

by Carl Zeiss Meditec AG

Ref 1345-518

VisuMax is a femtosecond ophthalmic solid-state laser system (EU MDD Class IIb; FDA Class II) made by Carl Zeiss Meditec AG, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI B-04049471095036) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04049471095036), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04049471095036 Basic UDI-DI 04049471095036UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049471095036 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049471095036 registered 3 Aug 2026 Active
  • FDA GUDID UDI-DI 04049471095036 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049471095036
  2. Registered EUDAMED B-04049471095036

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Femtosecond ophthalmic solid-state laser system
Model / reference
1345-518 EUDAMED
VisuMax GUDID
Primary DI / UDI-DI
04049471095036
Basic UDI-DI
B-04049471095036
FDA product code
HQF, OTL, HNO
EMDN code
Z1212020501 Microkeratome lasers
GMDN term
Femtosecond ophthalmic solid-state laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
886.4390, 886.4370
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1345-518
GUDID
VisuMax
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Femtosecond ophthalmic solid-state laser system

Similar devices in this category

Other devices filed under INSTRUMENTS FOR MICROKERATOME SURGERY.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)