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Iu 3000-15

by aap Implantate AG

Ref IU 3000-15Model Instrument

Iu 3000-15 is a Class I device made by aap Implantate AG, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI B-04042409353284) and listed in FDA GUDID since 28 Feb 2018 (UDI-DI 04042409353284), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042409353284 Basic UDI-DI 04042409353284UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042409353284 UDI-DI Date28 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04042409353284 registered 17 Sep 2026 Active
  • FDA GUDID UDI-DI 04042409353284 listed 28 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04042409353284
  2. Registered EUDAMED B-04042409353284

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  • Withdrawn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

Generic name
Orthopaedic osteotome
Model / reference
IU 3000-15, Instrument
Primary DI / UDI-DI
04042409353284
Basic UDI-DI
B-04042409353284
FDA product code
FZO
EMDN code
L0923 Orthopaedics surgical measurers, reusable
GMDN term
Orthopaedic osteotome
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: Orthopaedic osteotome

Similar devices in this category

Other devices filed under ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE.

Other devices from aap Implantate AG

See all devices from aap Implantate AG →

Properties

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