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INITIALE modular broach N° 501

by Amplitude

Ref 8-0101251Model Hip_Femoral Broach

INITIALE modular broach N° 501 (8-0101251) is a Class IIa device made by Amplitude, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 3701089522A030109TImb0XS), active as of 25 Oct 2026.

Active European Union

CE MDR

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number3701089522A030109TImb0XS Basic UDI-DI 03701089533294UDI-DIDate3 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
Hip_Femoral Broach, 8-0101251
Primary DI / UDI-DI
03701089533294
Basic UDI-DI
3701089522A030109TImb0XS
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000003453

Other devices from Amplitude

See all devices from Amplitude →

Properties

  • Sterilise before use
  • Reusable
  • Reprocessed single-use device
Other properties (11, all answered No)