EU → North America Device Access

Toul Meditech AB

SE-MF-000005195 · Sweden · Västerås

Toul Meditech AB is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa8

Most frequent device types declared: Operio, SteriStay.

Among these devices, 2 are declared sterile, 6 active.

Devices declared under this manufacturer

Catalogue references include 7350101640005, 7350101640043, 7350101640142, LAF-02, LAF-02-D, SC180.

European nomenclature codes declared: V0899, T0210.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTOUL MEDITECH AB (SE) · FDA 3012992602
Devices in EUDAMED8
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN8
Found in the U.S. device database4
Share50.0 %

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. Toul Meditech AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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