EU → North America Device Access

Henrotek A/S

DK-MF-000029313 · Denmark · Rødding

Henrotek A/S 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: Technical aid for disable people, Technical aid for disabled.

Devices declared under this manufacturer

Catalogue references include Ref no. 12877, Ref no. 12878, Ref no. 12882, Ref no. 12883, Ref no. 12884, Ref no. 12885.

European nomenclature codes declared: Y0999.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHENROTEK A/S (DK) · FDA 3028012839
Devices in EUDAMED8
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN8
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. Henrotek A/S is registered in the United States but was not found in the Canadian register.

Other manufacturers in Denmark

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