EU → North America Device Access

Steroplast Healthcare Ltd

GB-MF-000018088 · United Kingdom · Manchester

Steroplast Healthcare Ltd is registered in the European database on medical devices as a manufacturer, with 194 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa194

Authorised representative in the Union: Advena Limited.

Catalogue references include 2082TL, 4053, 4154/10, 4160/30, 4589P, 6402-M17.

European nomenclature codes declared: M030402020101, H900299, M040499, R030199, M0304010102, M020107.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED194
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 GTIN194
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. Steroplast Healthcare Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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