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Gimmi AD.1606.01

by Gimmi GmbH

Ref AD.1606.01

Gimmi AD.1606.01 is a Class I device made by Gimmi GmbH, registered in EUDAMED on 6 Aug 2026 (Basic UDI-DI B-04049047016984) and listed in FDA GUDID since 29 Apr 2025 (UDI-DI 04049047016984), 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-04049047016984 Basic UDI-DI 04049047016984UDI-DIDate6 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049047016984 UDI-DI Date29 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04049047016984 registered 6 Aug 2026 Active
  • FDA GUDID UDI-DI 04049047016984 listed 29 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04049047016984
  2. Registered EUDAMED B-04049047016984

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  • Withdrawn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
Hand-held surgical retractor, reusable
Model / Ref / Catalog
AD.1606.01
Description
MIKULICZ RETRACTOR 95 X 35 MM LENGTH 260 MM
Primary DI / UDI-DI
04049047016984
Basic UDI-DI
B-04049047016984
FDA product code
GAD
EMDN code
L03140199 Spreaders and retractors for general surgery, reusable - other
GMDN term
Hand-held surgical retractor, reusable
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: Hand-held surgical retractor, reusable

Similar devices in this category

Other devices filed under SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER.

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)