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Rini Ergoteknik AB

SE-MF-000028740 · Sweden · Vallentuna

Rini Ergoteknik AB is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa10

Most frequent device types declared: 100-00105-0n, 120-00103-nn, 120-0010n-0n, 120-0010n-nn, 130-00105-nn.

Among these devices, 1 are declared active.

Devices declared under this manufacturer

Catalogue references include 100-00105-0n, 120-0010n-0n, 120-0010n-nn, 130-00105-nn 130-00105-nn, 130-00108-00, 130-0010n-nn or 170-0014n-nn.

European nomenclature codes declared: Y1803, Z12011202, V080202, Y093399, V08020199, V0805030101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryRINI ERGOTEKNIK AB (SE) · FDA 9710385
Devices in EUDAMED10
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database4
Share40.0 %

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. Rini Ergoteknik AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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