EU → North America Device Access

CryoIQ global AB

SE-MF-000010040 · Sweden · Onsala

CryoIQ global AB is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa46

Most frequent device types declared: CryoIQ.

Among these devices, 36 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 46 declared devices.

Catalogue references include CIQ-DA-C, CIQ-PA-BY, CIQ-PA-C1, CIQ-PA-C1-7, CIQ-PA-C3, CIQ-PA-D3.

European nomenclature codes declared: Z120102.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCryoIQ global AB (SE) · FDA 3012913237
Devices in EUDAMED46
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN46
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: United States only. CryoIQ global AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

All Sweden manufacturers →