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Endoflator UI500

by Karl Storz SE & CO. KG

Ref UI500

Endoflator UI500 is a device classified as Class IIb in the EU and Class II in the US made by Karl Storz SE & CO. KG, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 4048551001266TT) and listed in FDA GUDID since 23 Feb 2019 (UDI-DI 04048551326657), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048551001266TT Basic UDI-DI 04048551326657UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048551326657 UDI-DI Date23 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048551001266TT registered 19 May 2026 Active
  • FDA GUDID UDI-DI 04048551326657 listed 23 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048551326657
  2. Registered EUDAMED 4048551001266TT

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  • Withdrawn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
Endoflator
Generic name
Laparoscopic insufflator
Device name
Insufflators, heating
Model / reference
UI500
Primary DI / UDI-DI
04048551326657
Basic UDI-DI
4048551001266TT
FDA product code
FCX
EMDN code
Z12029008 Gas inflators
GMDN term
Laparoscopic insufflator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500
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
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: Laparoscopic insufflator

Similar devices in this category

Other devices filed under GAS INFLATORS.

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Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)