EU → North America Device Access

GM Instruments Ltd

GB-MF-000020565 · United Kingdom · Irvine

GM Instruments Ltd is registered in the European database on medical devices as a manufacturer, with 55 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa55

Most frequent device types declared: A1 Acoustic Rhinometer, Accoson Examination Light, Accoson Pressure Infusion Cuff, Accoson Stethoscope, Aneroid Sphygmomanometers.

Among these devices, 17 are declared active, 50 with a measuring function.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 55 declared devices.

Catalogue references include 0205, 0292A, 0322AS, 0329A, 0360, 0700.

European nomenclature codes declared: Z1203020599, A088099, Z129004, Z12149008, Z12159010, Z12149009.

United States market access

FDA establishment registerRegistered with FDA
Matched entryG.M. INSTRUMENTS LTD. (GB) · FDA 8040391
Devices in EUDAMED55
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN55
Found in the U.S. device database2
Share3.6 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryGM INSTRUMENTS LTD.

North American profile: Both markets. GM Instruments Ltd is registered in both the United States and Canada.

Other manufacturers in United Kingdom

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