EU → North America Device Access

DIERS International GmbH

DE-MF-000014266 · Germany · Wiesbaden

DIERS International GmbH is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa16

Among these devices, 16 are declared active, 8 with a measuring function.

Catalogue references include 3013, 3014, 303A, 312, 403, 505.

European nomenclature codes declared: Z12062503, Z12062501, Z12062603, Z12100701, Z129006, Z12062601.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDIERS INTERNATIONAL GMBH (DE) · FDA 3006644670
Devices in EUDAMED16
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN16
Found in the U.S. device database13
Share81.2 %

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. DIERS International GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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