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Profemur Gladiator Plasma Classic Stem

by MicroPort Orthopedics Inc. 20 variants

Ref PRGLCLE3

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

CE MDR

Valid until

3 Jul 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier ITALCERT SRL

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0192629PROFGPCSCLAZ Basic UDI-DI 00192629096899UDI-DIDate31 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00192629096899 UDI-DI Date20 Oct 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 023-00-00-MDR Active Supplemented

    Technical documentation EU MDR

    Certifier
    ITALCERT SRL 0426
    Issued
    4 Jul 2023
    Expires
    3 Jul 2028
    Reason
    Other

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  • Withdrawn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
Profemur®
Generic Name
Press-fit hip femur prosthesis, one-piece
Device Name
Profemur Gladiator Plasma Classic Stem
Model / Ref / Catalog
PRGLCLE3
Primary DI / UDI-DI
00192629096899 EUDAMED
M684PRGLCLE31 GUDID
Basic UDI-DI
0192629PROFGPCSCLAZ
Secondary DI
M684PRGLCLE31
FDA Product Code
LZO
EMDN Code
P090804010202 Uncemented femoral stems for primary implant, with fixed neck, anatomical
GMDN Term
Press-fit hip femur prosthesis, one-piece
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00192629096899
GUDID
M684PRGLCLE31
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000010240
Authorised representative
MicroPort Scientific Coöperatief U.A. NL-AR-000007340

Other devices from MicroPort Orthopedics Inc.

See all devices from MicroPort Orthopedics Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No