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Profemur® APA04243

by MicroPort Orthopedics Inc.

Ref APA04243

Profemur® APA04243 is a device classified as Class IIa in the EU and Class I in the US made by MicroPort Orthopedics Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 0192629IIAHL091201FE) and listed in FDA GUDID since 7 Mar 2017 (UDI-DI 00192629053458), 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 Number0192629IIAHL091201FE Basic UDI-DI 00192629053458UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00192629053458 UDI-DI Date7 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0192629IIAHL091201FE registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00192629053458 listed 7 Mar 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00192629053458
  2. Registered EUDAMED 0192629IIAHL091201FE

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  • Withdrawn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
Straight Broach Handle for Pneumatic System EUDAMED
Profemur® GUDID
Generic name
Joint prosthesis implantation kit, reusable
Device name
Hip Orthopaedic Surgery Rasps, Reusable
Model / Ref / Catalog
APA04243
Primary DI / UDI-DI
00192629053458 EUDAMED
M684APA042431 GUDID
Basic UDI-DI
0192629IIAHL091201FE
Secondary DI
M684APA042431
Direct marketing DI
00192629053458
FDA product code
HWT
EMDN code
L091201 Orthopaedic surgery rasps, reusable
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00192629053458
GUDID
M684APA042431
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00192629053458; FDA GUDID lists M684APA042431), so their flags are not compared. 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: Joint prosthesis implantation kit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RASPS, REUSABLE.

Other devices from MicroPort Orthopedics Inc.

See all devices from MicroPort Orthopedics Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)