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Gimmi AD.1063.18

by Gimmi GmbH

Ref AD.1063.18

Gimmi AD.1063.18 is a Class I device made by Gimmi GmbH, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-04049047686835) and listed in FDA GUDID since 24 Apr 2025 (UDI-DI 04049047686835), 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-04049047686835 Basic UDI-DI 04049047686835UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047686835 UDI-DI Date24 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049047686835 registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 04049047686835 listed 24 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049047686835
  2. Registered EUDAMED B-04049047686835

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  • Withdrawn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
Nerve/vessel retractor
Device name
Skin Hook
Model / Ref / Catalog
AD.1063.18
Description
SKIN HOOK 90° LENGTH 185 MM
Primary DI / UDI-DI
04049047686835
Basic UDI-DI
B-04049047686835
FDA product code
GZX
EMDN code
L110502 Nerves and vessels hook retractors, reusable
GMDN term
Nerve/vessel retractor
Device class
Class I
Regulation number
882.4525
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: Nerve/vessel retractor

Similar devices in this category

Other devices filed under NEUROSURGERY AND SPINAL SURGERY INSTRUMENTS, 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)