EU → North America Device Access

BPR Medical Limited

GB-MF-000003347 · United Kingdom · Mansfield

BPR Medical Limited is registered in the European database on medical devices as a manufacturer, with 73 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa67
Class IIb6

Most frequent device types declared: 816-0016, 816-0047, 818-0009, 818-0018, 827-2001.

Among these devices, 14 are declared active, 1 with a measuring function.

Authorised representative in the Union: QbD RepS BV.

Devices declared under this manufacturer

Showing 12 of 73 declared devices.

Catalogue references include 828-0001, 828-0013, 828-0041, 828-1004, 828-3003, 828-3006.

European nomenclature codes declared: Z120499, R9099, Z120309, Z1203019080, R03010280, R040101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryBPR MEDICAL LIMITED (GB) · FDA 9681409
Devices in EUDAMED73
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN73
Found in the U.S. device database7
Share9.6 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryBPR MEDICAL LTD.

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2008-10-15

Licence types: Device Family (2), System (1).

Licensed under: FIRESAFE OXYGEN ADAPTORS AND CONNECTORS, OXYGEN MICRO DIAL-FLOWMETER, ANALGESIC AND OXYGEN DEMAND VALVE SYSTEM.

North American profile: Both markets. BPR Medical Limited is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
GB26/00000017issued2031-02-16

Other manufacturers in United Kingdom

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