EU → North America Device Access

Diagramm Halbach GmbH & Co. KG

DE-MF-000012732 · Germany · Schwerte

Diagramm Halbach GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 187 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa187

Among these devices, 169 are declared with a measuring function.

Devices declared under this manufacturer

Showing 12 of 187 declared devices.

Catalogue references include 706265, 706290, 712120, 714660, 715045, 715050.

European nomenclature codes declared: Z1302.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED187
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 GTIN187
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. Diagramm Halbach GmbH & Co. KG was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
44910230746supplemented2029-07-21

Other manufacturers in Germany

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