EU → North America Device Access

Turon MedTech AB

SE-MF-000033162 · Sweden · Varberg

Turon MedTech AB is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa16

Among these devices, 7 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 020301, 020307, 020308, 020309, 020311, 020503.

European nomenclature codes declared: A018002.

United States market access

FDA establishment registerRegistered with FDA
Matched entryTURON MEDTECH AB (SE) · FDA 3007335051
Devices in EUDAMED16
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN16
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. Turon MedTech AB is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
28620168400issued2028-10-29

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