EU → North America Device Access

Ab HUR Oy

FI-MF-000008012 · Finland · Kokkola

Ab HUR Oy is registered in the European database on medical devices as a manufacturer, with 85 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa85

Among these devices, 12 are declared with a measuring function.

Devices declared under this manufacturer

Showing 12 of 85 declared devices.

Catalogue references include 5125, 5530, 5546, 9130, ST5330-Hi5-MD, ST9160-Hi5-MD.

European nomenclature codes declared: Y0599, Z120602.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED85
Country of registrationFinland

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN85
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. Ab HUR Oy was not found in either the U.S. or the Canadian register.

Other manufacturers in Finland

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