EU → US Device Access

Aseptika Limited

UK-MF-000037607 · United Kingdom · St Ives, Cambridgeshire

Aseptika Limited is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Most frequent device types declared: P060/P175, P111, P162, P161, P163.

Among these devices, 5 are declared active.

Authorised representative in the Union: IE-AR-000003999.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
Country of registrationUnited Kingdom
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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