EU → North America Device Access

Drive DeVilbiss Healthcare Limited

GB-MF-000012818 · United Kingdom · Halifax

Drive DeVilbiss Healthcare Limited is registered in the European database on medical devices as a manufacturer, with 479 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa479

Most frequent device types declared: Apollo II dynamic cushion (surface only), Apollo II dynamic system, Apollo Infant dynamic system, Apollo Junior dynamic system, Artemis II dynamic cushion (surface only).

Among these devices, 58 are declared active.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 479 declared devices.

Catalogue references include 10283-30, BRAD/STD/NI, SOS10040B/S, SOS10041SG, SOS10046BL, SOS10048PB/O.

European nomenclature codes declared: Y180980, V08060101, V08030102, V080702, Y120606, Y120603.

United States market access

FDA establishment registerRegistered with FDA
Matched entryDrive DeVilbiss Healthcare (US) · FDA 3043460907
Devices in EUDAMED479
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN479
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: United States only. Drive DeVilbiss Healthcare Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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