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CALLISTO eye 3.7

by Carl Zeiss Meditec AG

Ref 0441

CALLISTO eye 3.7 is a device classified as Class IIa in the EU and Class II in the US made by Carl Zeiss Meditec AG, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 4049539_00000002_AC) with CE/MDR certificate 1000335292 valid until 5 Jan 2027 and listed in FDA GUDID since 26 Aug 2019 (UDI-DI 04049539104410), expiring as of 25 Oct 2026.

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

CE MDR

Valid until

5 Jan 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000335292 Date16 Sep 2026IssuedStatusExpiring expires 5 Jan 2027
United StatesGUDID listing GUDID Number04049539104410 UDI-DI Date26 Aug 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049539_00000002_AC registered 23 Jul 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04049539104410 listed 26 Aug 2019 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000335292 Expiring Supplemented Expires in 52 days

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    16 Sep 2026
    Expires
    5 Jan 2027
    Reason
    Add device or group
  • 1000335292 Expiring Supplemented Expires in 52 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

Timeline

4 dated events

  1. Listed FDA GUDID 04049539104410
  2. Registered EUDAMED 4049539_00000002_AC
  3. Certificate issued EUDAMED 1000335292
  4. Certificate expires EUDAMED 1000335292

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CALLISTO eye Software EUDAMED
CALLISTO eye GUDID
Generic name
Operating room audiovisual data/device management system
Model / reference
0441 EUDAMED
3.7 GUDID
Primary DI / UDI-DI
04049539104410
Basic UDI-DI
4049539_00000002_AC
FDA product code
NFJ
EMDN code
Z12120292 Therapeutic and surgical ophtholmological treatments instruments - medical device software
GMDN term
Operating room audiovisual data/device management system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0441
GUDID
3.7
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Operating room audiovisual data/device management system

Similar devices in this category

Other devices filed under THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS.

Other devices from Carl Zeiss Meditec AG

See all devices from Carl Zeiss Meditec AG →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)