EU → North America Device Access

ARCO Ltd.

GB-MF-000033950 · United Kingdom · Hull

ARCO Ltd. is registered in the European database on medical devices as a manufacturer, with 73 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa73

Most frequent device types declared: ARCO HC101 Exam Gloves - Blue Medical Grade Nitrile Disposable Gloves, ARCO HC103 Exam Gloves - Blue Long Cuff Medical Grade Nitrile Disposab, ARCO HC104 Exam Gloves - Blue Medical Grade Nitrile Disposable Gloves, ARCO HC105 Exam Gloves - Blue Medical Grade Nitrile Disposable Gloves, ARCO HC106 Exam Gloves - Blue Medical Grade Nitrile Disposable Gloves.

Authorised representative in the Union: European Healthcare & Device Solutions Ltd..

Devices declared under this manufacturer

Showing 12 of 73 declared devices.

Catalogue references include 1426304, 1426307, 14HC407, 14HC509, 14HC607, 14HC706.

European nomenclature codes declared: T01020204.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED73
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 GTIN73
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. ARCO Ltd. was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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