EU → North America Device Access

MTS Medical AG (Aktiengesellschaft)

DE-MF-000005447 · Germany · Konstanz

MTS Medical AG (Aktiengesellschaft) is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb8

Most frequent device types declared: OW100/OW100S, OW280.

Among these devices, 8 are declared active.

Devices declared under this manufacturer

Catalogue references include 1000001, 1000002, 1000003, 1000008, 1000009, 1000010.

European nomenclature codes declared: Z12139001, Z12160101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. MTS Medical AG (Aktiengesellschaft) was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →