EU → North America Device Access

EMS Physio ltd

GB-MF-000029343 · United Kingdom · Irvine

EMS Physio ltd is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb14

Most frequent device types declared: Primo 1MHz ultrasound, Primo Ultrasound & Electrical Simulation, Primo combination therapy, Primo dual frequency ultrasound, Primo interferential.

Among these devices, 14 are declared active.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Showing 12 of 14 declared devices.

Catalogue references include EMS265, EMS3601, EMS460, EMS560, EMS860, EMS960.

European nomenclature codes declared: Z120601, Z12139001, Z120609.

United States market access

FDA establishment registerRegistered with FDA
Matched entryEMS PHYSIO LTD. (GB) · FDA 3004154499
Devices in EUDAMED14
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN14
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryEMS PHYSIO LTD.

North American profile: Both markets. EMS Physio ltd is registered in both the United States and Canada.

Other manufacturers in United Kingdom

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