EU → North America Device Access

Pulse for Integrated Solutions GmbH

DE-MF-000024533 · Germany · Unterschleißheim

Pulse for Integrated Solutions GmbH is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Most frequent device types declared: 4262384740033, Model 1, Model 2.

Among these devices, 9 are declared active.

Devices declared under this manufacturer

Catalogue references include 4262384740019, 4262384740026, 4262384740033, 4262384740057, 4262384740064, 4262384740071.

European nomenclature codes declared: Z12030601.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. Pulse for Integrated Solutions GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →