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Gimmi GK.2011.04

by Gimmi GmbH

Ref GK.2011.04

Gimmi GK.2011.04 is an endometrial biopsy curette (EU MDD Class I; FDA Class I; FDA product code FZS, Curette, Surgical, General Use) made by Gimmi GmbH, registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI B-04049047701743) and listed in FDA GUDID since 14 May 2025 (UDI-DI 04049047701743), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04049047701743 Basic UDI-DI 04049047701743UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047701743 UDI-DI Date14 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049047701743 registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 04049047701743 listed 14 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049047701743
  2. Registered EUDAMED B-04049047701743

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  • Withdrawn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
Gimmi
Generic name
Endometrial biopsy curette
Model / Ref / Catalog
GK.2011.04
Description
MIKRODISECTOMY CURETTE CERVICAL FIG. 0000, ANGLED, FORWARD LENGTH 210 MM, NOT FOR NEURO AND CARDIO
Primary DI / UDI-DI
04049047701743
Basic UDI-DI
B-04049047701743
FDA product code
FZS
EMDN code
L1199 Neurosurgery instruments, reusable - other
GMDN term
Endometrial biopsy curette
Device class
Class I
Regulation number
878.4800
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

Related devices

Category: Endometrial biopsy curette

Similar devices in this category

Other devices filed under NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)