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Profemur Gladiator Classic Standard Stem

by MicroPort Orthopedics Inc. 5 variants

Ref PRGCCMS6

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

CE MDR

Valid until

3 Jul 2028

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

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 Number0192629PROFGCSSCN7 Basic UDI-DI 00192629250116UDI-DIDate31 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00192629250116 UDI-DI Date21 Dec 2020ListedStatusListed 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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Uncoated femoral stem prosthesis, one-piece
Device Name
Profemur Gladiator Classic Standard Stem
Model / Ref / Catalog
PRGCCMS6
Primary DI / UDI-DI
00192629250116
Basic UDI-DI
0192629PROFGCSSCN7
Secondary DI
M684PRGCCMS61
510(k) Number
FDA Product Code
LZO, KWY, KWL
EMDN Code
P090804010101 Cemented femoral stems for primary implant, with fixed neck, straight
GMDN Term
Uncoated femoral stem prosthesis, one-piece
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3353, 888.3390, 888.3360
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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