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Profemur® PRMOD450

by MicroPort Orthopedics Inc.

Ref PRMOD450

Profemur® PRMOD450 is a Class I device made by MicroPort Orthopedics Inc., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 0192629IRHL09040278) and listed in FDA GUDID since 30 Dec 2016 (UDI-DI 00192629096721), 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 Number0192629IRHL09040278 Basic UDI-DI 00192629096721UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00192629096721 UDI-DI Date30 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0192629IRHL09040278 registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00192629096721 listed 30 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00192629096721
  2. Registered EUDAMED 0192629IRHL09040278

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  • Withdrawn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® Box Chisel - Modular EUDAMED
Profemur® GUDID
Generic name
Joint prosthesis implantation kit, reusable
Device name
Hip ORTHOPAEDIC SURGERY SCALPELS, REUSABLE
Model / Ref / Catalog
PRMOD450
Primary DI / UDI-DI
00192629096721 EUDAMED
M684PRMOD4501 GUDID
Basic UDI-DI
0192629IRHL09040278
Secondary DI
M684PRMOD4501
Direct marketing DI
00192629096721
FDA product code
FZO
EMDN code
L090402 Orthopaedic surgery scalpels, reusable
GMDN term
Joint prosthesis implantation kit, reusable
Device class
Class I
Regulation number
878.4800
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 · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00192629096721
GUDID
M684PRMOD4501

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00192629096721; FDA GUDID lists M684PRMOD4501), so their flags are not compared.

Related devices

Category: Joint prosthesis implantation kit, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY SCALPELS, 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)