EU → North America Device Access

OSKA Care Ltd

GB-MF-000029351 · United Kingdom · Havant

OSKA Care Ltd is registered in the European database on medical devices as a manufacturer, with 13 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa13

Most frequent device types declared: Series2 Specialist Foam Mattress, Series4/Series4H Specialist Foam Mattress System, Series5 Mattress, Series6 Mattress.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 13 declared devices.

Catalogue references include PR13-009, PR13-022, PR13-333, PR13-555, PR13-601, PR13-606.

European nomenclature codes declared: V080702.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED13
Country of registrationUnited Kingdom

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

Device-level evidence

Devices with a numeric GTIN13
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. OSKA Care Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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