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Zeiss Connect 2.0

by Carl Zeiss Meditec AG

Ref 7013

Zeiss Connect 2.0 is a medical device (EU MDR Class I; FDA Class I; FDA product code KQM, Camera, Surgical And Accessories; EMDN category medical device software - not included in other classes) made by Carl Zeiss Meditec AG, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 4049471_ZC001_YH) and listed in FDA GUDID since 3 Aug 2018 (UDI-DI 04049539070135), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4049471_ZC001_YH Basic UDI-DI 04049539070135UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049539070135 UDI-DI Date3 Aug 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4049471_ZC001_YH registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 04049539070135 listed 3 Aug 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049539070135
  2. Registered EUDAMED 4049471_ZC001_YH

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  • Withdrawn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
Zeiss Connect
Generic name
Multidisciplinary medical image management software
Model / reference
7013 EUDAMED
2.0 GUDID
Primary DI / UDI-DI
04049539070135
Basic UDI-DI
4049471_ZC001_YH
FDA product code
KQM
EMDN code
V92 Medical device software - not included in other classes
GMDN term
Multidisciplinary medical image management software
Device class
Class I
Regulation number
878.4160
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
7013
GUDID
2.0

Related devices

Category: Multidisciplinary medical image management software

Similar devices in this category

Other devices filed under MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES.

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Properties

  • Premarket exempt
Other properties (24, all answered No)