EU → North America Device Access

Harvest Healthcare

GB-MF-000011160 · United Kingdom · Rotherham

Harvest Healthcare is registered in the European database on medical devices as a manufacturer, with 56 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa56

Most frequent device types declared: Community Modular Foam, Duke Active Mattress, Kinetic Air Hybrid Mattress, Static Mattress.

Authorised representative in the Union: Evolution Healthcare Ltd.

Devices declared under this manufacturer

Showing 12 of 56 declared devices.

Catalogue references include HAMHAMP001P1, HFC129.01BR, HFC143, HFIM2016.12, HR440.P2, HSMCOMP.

European nomenclature codes declared: V080702, V08030101, V080701.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED56
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 GTIN56
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. Harvest Healthcare was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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