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Iu 6008-11

by aap Implantate AG

Ref IU 6008-11Model Instrument

Iu 6008-11 is a Class I device made by aap Implantate AG, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI B-04042409402043) and listed in FDA GUDID since 28 Feb 2018 (UDI-DI 04042409402043), 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-04042409402043 Basic UDI-DI 04042409402043UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042409402043 UDI-DI Date28 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04042409402043 registered 17 Sep 2026 Active
  • FDA GUDID UDI-DI 04042409402043 listed 28 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04042409402043
  2. Registered EUDAMED B-04042409402043

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  • Withdrawn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
Bone lever/elevator, reusable
Model / reference
IU 6008-11, Instrument
Primary DI / UDI-DI
04042409402043
Basic UDI-DI
B-04042409402043
FDA product code
LXH
EMDN code
L0902 Orthopaedic surgery levers, reusable
GMDN term
Bone lever/elevator, reusable
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: Bone lever/elevator, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY LEVERS, REUSABLE.

Other devices from aap Implantate AG

See all devices from aap Implantate AG →

Properties

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