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Biomet® 32-341533

by Biomet Orthopedics, Inc.

Ref 32-341533

Biomet® 32-341533 is a device classified as Class IIa in the EU and Class I in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024BCU2A) and listed in FDA GUDID since 2 Apr 2022 (UDI-DI 00887868483196), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024BCU2A Basic UDI-DI 00887868483196UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868483196 UDI-DI Date2 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024BCU2A registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868483196 listed 2 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868483196
  2. Registered EUDAMED 889024BCU2A

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  • Withdrawn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

Trade name
Biomet®
Generic name
Bone-resection orthopaedic reamer, reusable
Device name
Maxim Tibial Offset Reamer
Model / Ref / Catalog
32-341533
Primary DI / UDI-DI
00887868483196
Basic UDI-DI
889024BCU2A
Direct marketing DI
00887868483196
FDA product code
HTO
EMDN code
L091102 Orthopaedic prostheses reamers and burs, reusable
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
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: Bone-resection orthopaedic reamer, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)