EU → US Device Access

Kobayashi Healthcare Europe Limited

GB-MF-000012185 · United Kingdom · LONDON

Kobayashi Healthcare Europe Limited is registered in the European database on medical devices as a manufacturer, with 17 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa17

Most frequent device types declared: Cura-Heat Back and Shoulder Indirect 3P , Cura-Heat Back and Shoulder Pain Indirect 1P, Cura-Heat Wide Cover Direct 2P, Cura-Heat Arthritis/Knee Pain 4P&1Wrap, Cura-Heat Acute Back Pain Max Size Indirect 2P.

Authorised representative in the Union: IE-AR-000002496.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED17
Country of registrationUnited Kingdom
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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