EU → North America Device Access

Heinz Kurz GmbH

DE-MF-000007959 · Germany · Dusslingen

Heinz Kurz GmbH is registered in the European database on medical devices as a manufacturer, with 381 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb354
Class IIa27

Most frequent device types declared: Stapedioplasty prosthesis, Tympanoplasty Prosthesis, Tympanoplasty prosthesis, Ventilation Tube.

Among these devices, 357 are declared sterile, 354 implantable, 19 reusable, 1 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 381 declared devices.

Catalogue references include 1002034, 1002610, 1004240, 1004242, 1007208, 1007261.

European nomenclature codes declared: P02010102, P02010101, P020180, Q0299, L149099, P02010103.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED381
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN381
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryHEINZ KURZ GMBH

What it holds in Canada

Licences on record3
Currently active0
Class 3 devices3
First licensed2006-02-10

Licence types: Device Family (3).

Licensed under: OSSICULAR PROSTHESES - TITANIUM, OMEGA CONNECTOR TITANIUM, NITIBOND STAPES PROSTHESIS - NITIFLEX STAPES P.

North American profile: Canada only. Heinz Kurz GmbH holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Germany

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