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S.0329.31

by Gimmi GmbH

Ref S.0329.31

S.0329.31 is a Class I device made by Gimmi GmbH, registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-04049047782124) and listed in FDA GUDID since 13 Sep 2023 (UDI-DI 04049047782124), 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-04049047782124 Basic UDI-DI 04049047782124UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047782124 UDI-DI Date13 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049047782124 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 04049047782124 listed 13 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049047782124
  2. Registered EUDAMED B-04049047782124

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  • Withdrawn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
Cernicalo
Generic name
Suturing needle holder, reusable
Model / Ref / Catalog
S.0329.31
Primary DI / UDI-DI
04049047782124
Basic UDI-DI
B-04049047782124
FDA product code
FHQ
EMDN code
L1205 Laparoscopic and thoracoscopic surgery 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 LAPAROSCOPIC AND THORACOSCOPIC SURGERY 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)