EU → North America Device Access

PRISMAN GmbH

DE-MF-000009900 · Germany · Lorsch

PRISMAN GmbH is registered in the European database on medical devices as a manufacturer, with 237 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa200
Class IIb37

Most frequent device types declared: 121, 128, 350, 436, 450, 451, 452, 453, 454, 455.

Devices declared under this manufacturer

Showing 12 of 237 declared devices.

Catalogue references include 02287, 15515, 156 702, 2434NEUTRAL, 5722798, 750132.

European nomenclature codes declared: D0899, D0799, D0902, M020204, Q01010403, P0199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPRISMAN GMBH (DE) · FDA 3027692624
Devices in EUDAMED237
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN237
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: United States only. PRISMAN GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →