EU → US Device Access

Polyco Healthline Group Limited

GB-MF-000015289 · United Kingdom · Bourne, Lincolnshire

Polyco Healthline Group Limited is registered in the European database on medical devices as a manufacturer, with 182 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa181
other1

Most frequent device types declared: Nitrile Powder Free Examination Glove, Vinyl Powder Free Examination Glove, Medical Theatre Cap, Non-Sterile, Natural Latex Powder Free Examination Glove, Non Sterile Theatre Hood/Hijab.

Authorised representative in the Union: IE-AR-000002248.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED182
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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