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Iu 7065-22-1U

by aap Implantate AG

Ref IU 7065-22-1UModel Drill

Iu 7065-22-1U is a device classified as Class IIa in the EU and Class I in the US made by aap Implantate AG, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI B-04042409227493) and listed in FDA GUDID since 28 Feb 2018 (UDI-DI 04042409227493), 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-04042409227493 Basic UDI-DI 04042409227493UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042409227493 UDI-DI Date28 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04042409227493 registered 10 Sep 2026 Active
  • FDA GUDID UDI-DI 04042409227493 listed 28 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04042409227493
  2. Registered EUDAMED B-04042409227493

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  • Withdrawn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
Cannulated surgical drill bit, single-use
Model / reference
IU 7065-22-1U, Drill
Description
Drill CS 6.5, ø4.4, L 220, I-ø 2.6, Hudson coupling, single use
Primary DI / UDI-DI
04042409227493
Basic UDI-DI
B-04042409227493
FDA product code
HTW
EMDN code
Z12130599 Motorised orthopaedic surgery system instruments - other
GMDN term
Cannulated surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class I GUDID
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cannulated surgical drill bit, single-use

Similar devices in this category

Other devices filed under MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - OTHER.

Other devices from aap Implantate AG

See all devices from aap Implantate AG →

Properties

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