EU → North America Device Access

Nipro Pure Water GmbH

DE-MF-000016554 · Germany · Bruchsal

Nipro Pure Water GmbH is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa4
Class IIb14

Among these devices, 14 are declared active.

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include LiniXia DS, LiniXia DS Pro, Phoenix Basic, Phoenix Move, Phoenix One DS, Phoenix One DS+ FH.

European nomenclature codes declared: Z12099007, Z12099099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED18
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 GTIN18
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. Nipro Pure Water GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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