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VISULAS combi

by Carl Zeiss Meditec AG

Ref 2222-003Model VISULAS combi

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4049471_VL0004_2U Basic UDI-DI 04049471091496UDI-DIDate29 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049471091496 UDI-DI Date12 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000335292 Expiring Supplemented Expires in 64 days Removed from EUDAMED

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    16 Sep 2026
    Expires
    5 Jan 2027
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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

Trade Name
VISULAS combi EUDAMED
Visulas GUDID
Generic Name
General/multiple surgical frequency-doubled solid-state laser system
Model / Reference
VISULAS combi, 2222-003
Primary DI / UDI-DI
04049471091496
Basic UDI-DI
4049471_VL0004_2U
Direct Marketing DI
04049471091496
510(k) Number
FDA Product Code
HQF
EMDN Code
Z12120202, Z12120299
GMDN Term
General/multiple surgical frequency-doubled solid-state laser system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
886.4390
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Carl Zeiss Meditec AG

See all devices from Carl Zeiss Meditec AG →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

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