EU → North America Device Access

Body Clock Health Care Limited

GB-MF-000007381 · United Kingdom · London

Body Clock Health Care Limited is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa16

Most frequent device types declared: Boots Maternity TENS, ELLE TENS 2, Electrodes, Elle TENS, Elle TENS Plus.

Among these devices, 7 are declared active.

Authorised representative in the Union: MedEnvoy Global BV.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include CM32R, CM40100, CM5050, D-BC04T, D-BC06TB, D-BC09T.

European nomenclature codes declared: N010201, Z12062780.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBODY CLOCK HEALTH CARE LTD (GB) · FDA 9710616
Devices in EUDAMED16
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN16
Found in the U.S. device database2
Share12.5 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryBODY CLOCK HEALTH CARE LIMITED

North American profile: Both markets. Body Clock Health Care Limited is registered in both the United States and Canada.

Other manufacturers in United Kingdom

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