EU → North America Device Access

Sirius Distribution Ltd

UK-MF-000044978 · United Kingdom · Somerset,

Sirius Distribution Ltd is registered in the European database on medical devices as a manufacturer, with 104 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa104

Authorised representative in the Union: SUNGO Europe B.V..

Devices declared under this manufacturer

Showing 12 of 104 declared devices.

Catalogue references include ECOPFL, MEDFLM, METAFLM, NATPL, NATS, PFM.

European nomenclature codes declared: Y061203.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED104
Country of registrationUnited Kingdom

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN104
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: Neither register. Sirius Distribution Ltd was not found in either the U.S. or the Canadian register.

Other manufacturers in United Kingdom

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