Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022505514

FEI Number

3022505514

Entity Name

QTEC CE-MED GMBH

City/State/Country

Luebeck Schleswig-Holstein, DE

Establishment Address

Curtiusstr.27, Luebeck Schleswig-Holstein 23568, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

qtec CE-Med GmbH (Owner Number: 10084987)

Owner / Operator Contact Address

Curtiusstr.27, Luebeck, DE-SH 23568, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

m-protect3 Fisturasper

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2022-04-24
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-06-30

Official Correspondent

Timo Bohnhoff

US Agent Details

German American Chamber of Commerce, Inc. German American Ch Email: legalservices@gaccny.com Phone: (212) 9748830

Related Public Records

Same Entity

qtec CE-Med GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022505514. Last updated year: 2026. Please use registration number 3022505514 when referencing this establishment in official correspondence.