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Tmj System

by Biomet Microfixation 3 variants

Ref 01-6581

Tmj System (01-6581) is a Class IIb device made by Biomet Microfixation, Inc, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00841036070380), active as of 7 Nov 2026.

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00841036070380 Basic UDI-DI 00841036070380UDI-DIDate23 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
01-6581
Primary DI / UDI-DI
00841036070380
Basic UDI-DI
B-00841036070380
EMDN code
P010103 Mandibular prostheses
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001169
Authorised representative
Biomet Global Supply Chain Center B.V. NL-AR-000000422

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Implantable
Other properties (12, all answered No)