EU → North America Device Access

Injex Pharma GmbH

DE-MF-000006766 · Germany · Berlin

Injex Pharma GmbH is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8
Class IIb1

Most frequent device types declared: Ampoule U-100/0.3ml, Dosing Aid, Injex30, Luer-Adapter, Pen-Adapter.

Among these devices, 6 are declared sterile, 1 with a measuring function.

Devices declared under this manufacturer

Catalogue references include 338012000, 338013000, 511000400, 511000500, 511000600, 511000700.

European nomenclature codes declared: A070103, V80, V0380, A020201.

United States market access

FDA establishment registerRegistered with FDA
Matched entryINJEX PHARMA GMBH (DE) · FDA 3009339779
Devices in EUDAMED9
Country of registrationGermany

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: United States only. Injex Pharma GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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