EU → North America Device Access

Dr. Jean Bausch GmbH & Co. KG

DE-MF-000005577 · Germany · Köln

Dr. Jean Bausch GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 111 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa111

Most frequent device types declared: Arti-Brux®, Arti-Check®, Arti-Fol®, Arti-Spray®, Articulating Papers with progressive color transfer.

Among these devices, 4 are declared active.

Devices declared under this manufacturer

Showing 12 of 111 declared devices.

Catalogue references include BK 03, BK 142, BK 52, BK 61, BK 73, BK 74.

European nomenclature codes declared: Q01020299, Q01020201, Q010299, Q01020202, Q01020203, Q010599.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDr. Jean Bausch GmbH & Co. KG (DE) · FDA 8010224
Devices in EUDAMED111
Country of registrationGermany

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. Dr. Jean Bausch GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

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