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CALLISTO eye Panel PC Model II

by Carl Zeiss Meditec AG

Ref 6909

CALLISTO eye Panel PC Model II is a desktop computer (EU MDR Class I; FDA Class I; FDA product code LMD, System, Digital Image Communications, Radiological) made by Carl Zeiss Meditec AG, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 4049539_00000001_A9) and listed in FDA GUDID since 22 Sep 2017 (UDI-DI 04049539103512), active as of 23 Oct 2026.

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

CE MDR

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4049539_00000001_A9 Basic UDI-DI 04049539103512UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049539103512 UDI-DI Date22 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049539_00000001_A9 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 04049539103512 listed 22 Sep 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049539103512
  2. Registered EUDAMED 4049539_00000001_A9

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  • Withdrawn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
CALLISTO eye Panel PC
Generic name
Desktop computer
Model / reference
6909 EUDAMED
Model II GUDID
Primary DI / UDI-DI
04049539103512
Basic UDI-DI
4049539_00000001_A9
Direct marketing DI
04049539103512
FDA product code
LMD
EMDN code
Z12120280 Therapeutic and surgical ophtholmological treatments instruments - hardware accessories
GMDN term
Desktop computer
Device class
Class I
Regulation number
892.2020
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
6909
GUDID
Model II

Related devices

Category: Desktop computer

Similar devices in this category

Other devices filed under THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)