EU → North America Device Access

Bedtime AS

NO-MF-000036284 · Norway · Oslo

Bedtime AS is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa19

Most frequent device types declared: Bedtime formsydd glidelaken, Bedtime formsydd glidelaken med friksjonkant, UpRise Støttestang.

Devices declared under this manufacturer

Showing 12 of 19 declared devices.

Catalogue references include B-UR1000, B-UR1002, B-UR1003, BS124, Bedtime formsydd glidelaken, Bedtime formsydd glidelaken med friksjonkant.

European nomenclature codes declared: V080702, V08030102, Y181899, Y99, Y181806.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
Country of registrationNorway

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN19
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: Neither register. Bedtime AS was not found in either the U.S. or the Canadian register.

Other manufacturers in Norway

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