EU → North America Device Access

Four D Rubber Company Ltd

GB-MF-000012178 · United Kingdom · Heanor

Four D Rubber Company Ltd is registered in the European database on medical devices as a manufacturer, with 461 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa461

Most frequent device types declared: Dental Dam, Lifestyle - Exercise Band.

Among these devices, 1 are declared sterile.

Authorised representative in the Union: DEVMED International Limited.

Devices declared under this manufacturer

Showing 12 of 461 declared devices.

Catalogue references include BANDSLAITXPLU05512800, BANDSLFDJOPLU01510030, DENTALABDPGRN01815236, DENTALABIPGRN01812852, DENTALABIPGRN02812826, DENTALFGENISO02300510.

European nomenclature codes declared: Y0504.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED461
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 GTIN461
Found in the U.S. device database64
Share13.9 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

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. Four D Rubber Company Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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