Skip to content

Gimmi DA.1213.16

by Gimmi GmbH

Ref DA.1213.16

Gimmi DA.1213.16 is a Class I device made by Gimmi GmbH, registered in EUDAMED on 4 Sep 2026 (Basic UDI-DI B-04049047040644) and listed in FDA GUDID since 13 May 2025 (UDI-DI 04049047040644), 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-04049047040644 Basic UDI-DI 04049047040644UDI-DIDate4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047040644 UDI-DI Date13 May 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049047040644 registered 4 Sep 2026 Active
  • FDA GUDID UDI-DI 04049047040644 listed 13 May 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049047040644
  2. Registered EUDAMED B-04049047040644

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  • Withdrawn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
Spinal rongeur
Model / Ref / Catalog
DA.1213.16
Description
CASPAR LAMINECTOMY RONGEUR STRAIGHT, 3 X 12 MM LENGTH 165 MM
Primary DI / UDI-DI
04049047040644
Basic UDI-DI
B-04049047040644
FDA product code
HTX
EMDN code
L110604 Neurosurgery rongeurs, reusable
GMDN term
Spinal rongeur
Device class
Class I
Regulation number
888.4540
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: Spinal rongeur

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)