EU → North America Device Access

Biover AG

CH-MF-000036158 · Switzerland · Hergiswil

Biover AG is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa21

Among these devices, 14 are declared sterile, 7 reusable.

Authorised representative in the Union: Baxter Deutschland GmbH.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include MI 8012, MI 8013, MI 8040.1, TKFV-1, TKL-1, TKS-1.

European nomenclature codes declared: C0699, L1003, L1004.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBiover AG (CH) · FDA 9612773
Devices in EUDAMED21
Country of registrationSwitzerland

Device-level evidence

Devices with a numeric GTIN21
Found in the U.S. device database21
Share100.0 %

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. Biover AG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Switzerland

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