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Gimmi E.8290.11

by Gimmi GmbH

Ref E.8290.11

Gimmi E.8290.11 is a device classified as Class IIa in the EU and Class II in the US made by Gimmi GmbH, registered in EUDAMED on 4 Sep 2026 (Basic UDI-DI B-04049047042884) and listed in FDA GUDID since 5 May 2017 (UDI-DI 04049047042884), active as of 24 Oct 2026.

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

CE MDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04049047042884 Basic UDI-DI 04049047042884UDI-DIDate4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047042884 UDI-DI Date5 May 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049047042884 registered 4 Sep 2026 Active
  • FDA GUDID UDI-DI 04049047042884 listed 5 May 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049047042884
  2. Registered EUDAMED B-04049047042884

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
AlphaScope™ EUDAMED
Gimmi GUDID
Generic name
Rigid optical laparoscope
Model / Ref / Catalog
E.8290.11
Primary DI / UDI-DI
04049047042884
Basic UDI-DI
B-04049047042884
FDA product code
GCJ
EMDN code
Z12029009 Laparoscopes
GMDN term
Rigid optical laparoscope
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Rigid optical laparoscope

Similar devices in this category

Other devices filed under LAPAROSCOPES.

Other devices from Gimmi GmbH

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Serial number
Other properties (21, all answered No)