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Gimmi AE.1653.13

by Gimmi GmbH

Ref AE.1653.13

Gimmi AE.1653.13 is a Class I device made by Gimmi GmbH, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-04049047021988) and listed in FDA GUDID since 6 May 2025 (UDI-DI 04049047021988), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04049047021988 Basic UDI-DI 04049047021988UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047021988 UDI-DI Date6 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049047021988 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04049047021988 listed 6 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049047021988
  2. Registered EUDAMED B-04049047021988

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  • Withdrawn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
Suturing needle holder, reusable
Model / Ref / Catalog
AE.1653.13
Description
FRENCH (RYDER) NEEDLE HOLDER TC, SERRATED LENGTH 130 MM
Primary DI / UDI-DI
04049047021988
Basic UDI-DI
B-04049047021988
FDA product code
FHQ
EMDN code
L0205 Needle holders, reusable
GMDN term
Suturing needle holder, reusable
Device class
Class I
Regulation number
876.4730
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: Suturing needle holder, reusable

Similar devices in this category

Other devices filed under NEEDLE HOLDERS, REUSABLE.

Other devices from Gimmi GmbH

See all devices from Gimmi GmbH →

Properties

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