EU → North America Device Access

PROACT Medical Ltd.

GB-MF-000006294 · United Kingdom · Corby

PROACT Medical Ltd. is registered in the European database on medical devices as a manufacturer, with 469 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa469

Among these devices, 70 are declared active.

Authorised representative in the Union: Acorn Regulatory Consultancy Services Ltd.

Devices declared under this manufacturer

Showing 12 of 469 declared devices.

Catalogue references include APCD24310, APCD24360, APCD26005, APCR40049, HYCVHNC2, MMCB90MIL3.

European nomenclature codes declared: Z12040180, R9002, Z12021003, L031312, A030104, L01040199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPROACT MEDICAL LTD (GB) · FDA 3004863697
Devices in EUDAMED469
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN469
Found in the U.S. device database197
Share42.0 %

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: United States only. PROACT Medical Ltd. is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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