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Iu 8166-06

by aap Implantate AG

Ref IU 8166-06Model Instrument

Iu 8166-06 is a Class I device made by aap Implantate AG, registered in EUDAMED on 29 May 2026 (Basic UDI-DI 40424090132GX) and listed in FDA GUDID since 28 Feb 2018 (UDI-DI 04042409384516), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

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/MDR EUDAMED Number40424090132GX Basic UDI-DI 04042409384516UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042409384516 UDI-DI Date28 Feb 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40424090132GX registered 29 May 2026 Active
  • FDA GUDID UDI-DI 04042409384516 listed 28 Feb 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04042409384516
  2. Registered EUDAMED 40424090132GX

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Surgical depth gauge, reusable
Model / reference
IU 8166-06, Instrument
Primary DI / UDI-DI
04042409384516
Basic UDI-DI
40424090132GX
FDA product code
HTJ
EMDN code
L098099 Orthopaedic and traumatological surgery instruments, reusable - other accessories
GMDN term
Surgical depth gauge, reusable
Device class
Class I
Regulation number
888.4300
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical depth gauge, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES.

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)