EU → North America Device Access

Medovate Limited

GB-MF-000013729 · United Kingdom · Mildenhall

Medovate Limited is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb5

Most frequent device types declared: SAFIRA Driver, SAFIRA Foot Pedal, SAFIRA Palm Operator, SAFIRA Syringe Luer, SAFIRA Syringe NRFit.

Among these devices, 2 are declared sterile, 5 active.

Authorised representative in the Union: Advena Limited.

Devices declared under this manufacturer

Catalogue references include 900016, 900029, 900044, 900058, 900059.

European nomenclature codes declared: A0580, A020199, A0599.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMEDOVATE LIMITED (GB) · FDA 3016509758
Devices in EUDAMED5
Country of registrationUnited Kingdom

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database5
Share100.0 %

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. Medovate Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in United Kingdom

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