Profemur® 20070080: CE/MDR Class I

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0192629IRHL0902R3 Basic UDI-DI 00192629096677UDI-DI	Date3 Nov 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00192629096677 UDI-DI	Date2 Mar 2017Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 0192629IRHL0902R3 — open Devices and search for it

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 0192629IRHL0902R3 registered 3 Nov 2026 Active
FDA GUDID UDI-DI 00192629096677 listed 2 Mar 2017 Listed

Timeline

2 dated events

2 Mar 2017 Listed FDA GUDID 00192629096677
3 Nov 2026 Registered EUDAMED 0192629IRHL0902R3

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: Mueller Neck Elevator EUDAMED
Profemur® GUDID
Generic name: Joint prosthesis implantation kit, reusable
Device name: Hip ORTHOPAEDIC SURGERY LEVERS, REUSABLE
Model / Ref / Catalog: 20070080

Primary DI / UDI-DI: 00192629096677 EUDAMED
M684200700801 GUDID
Basic UDI-DI: 0192629IRHL0902R3
Secondary DI: M684200700801
Direct marketing DI: 00192629096677
FDA product code: GAD
EMDN code: L0902 Orthopaedic surgery levers, 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

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED 00192629096677	GUDID M684200700801

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00192629096677; FDA GUDID lists M684200700801), so their flags are not compared.