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Profemur® APA02146

by MicroPort Orthopedics Inc.

Ref APA02146

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0192629IIAHL0999U3 Basic UDI-DI 00192629043732UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00192629043732 UDI-DI Date2 Mar 2017ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Femoral Head Trial 36mm Long EUDAMED
Profemur® GUDID
Generic Name
Joint prosthesis implantation kit, reusable
Device Name
Hip Orthopaedic and Traumatological Surgery Instruments, Reusable - Other
Model / Ref / Catalog
APA02146
Primary DI / UDI-DI
00192629043732 EUDAMED
M684APA021461 GUDID
Basic UDI-DI
0192629IIAHL0999U3
Secondary DI
M684APA021461
Direct Marketing DI
00192629043732
FDA Product Code
HWT
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Joint prosthesis implantation kit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4800
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00192629043732
GUDID
M684APA021461
Device ClassEUDAMED
Class IIa
GUDID
Class I

Other devices from MicroPort Orthopedics Inc.

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Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No