EU → North America Device Access

DWA Dialyse Wasser Aufbereitungsanlagen GmbH & Co. KG

DE-MF-000008370 · Germany · Ubstadt-Weiher

DWA Dialyse Wasser Aufbereitungsanlagen GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 643 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa252
Class IIb391

Among these devices, 643 are declared active.

Devices declared under this manufacturer

Showing 12 of 643 declared devices.

Catalogue references include 01HRO417DXXXS, 01NPORT110, 01NPTPR1D, 01NPTPR2UD, 01NPURE363, 03CE00122.

European nomenclature codes declared: Z12099007, Z12099006, Z12011301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED643
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 GTIN643
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. DWA Dialyse Wasser Aufbereitungsanlagen GmbH & Co. KG was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
44911150580supplemented2028-05-04

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