EU → North America Device Access

Baxter Medical Systems GmbH + Co. KG

DE-MF-000005071 · Germany · Saalfeld

Baxter Medical Systems GmbH + Co. KG is registered in the European database on medical devices as a manufacturer, with 406 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa404
Class IIb2

Among these devices, 122 are declared active.

Devices declared under this manufacturer

Showing 12 of 406 declared devices.

Catalogue references include 1296096, 1582709, 1909813, 2070308, 2078594, 4058120.

European nomenclature codes declared: Z12011280, Z12011202, Z12010701, Z12019099, Z129007, V0402.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBaxter Medical Systems GmbH + Co. KG (DE) · FDA 3007143268
Devices in EUDAMED406
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN406
Found in the U.S. device database374
Share92.1 %

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. Baxter Medical Systems GmbH + Co. KG is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
HZ 1786593-1issued2029-03-23

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