Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010364775

FEI Number

3010364775

Entity Name

GEMUE GMBH

City/State/Country

Emmen Luzern, CH

Establishment Address

Seetalstrasse 210, Emmen Luzern 6032, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GEMUE GMBH (Owner Number: 10043523)

Owner / Operator Contact Address

Seetalstrasse 210, Emmen, CH-LU 6032, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

04.233.124.4 RFN L37.5 ø6.55 22° I.MOLDED PEEK INLY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-03-31

Official Correspondent

Roger Dubach

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

GEMUE GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04

Similar Registrations

Registration Number	Establishment Name	Location
3018182995	LOLL FEINMECHANIK GMBH	Tornesch Schleswig-Holstein, DE
3008599979	THE ORTHOPAEDIC IMPLANT COMPANY	Reno, NV, US
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3009732568	BGS BETA-GAMMA-SERVICE GMBH & CO KG	Wiehl North Rhine-Westphalia, DE
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010364775. Last updated year: 2026. Please use registration number 3010364775 when referencing this establishment in official correspondence.