EU → US Device Access

Outside In (Cambridge) Ltd trading as Lumie

GB-MF-000009152 · United Kingdom · Cambridge

Outside In (Cambridge) Ltd trading as Lumie is registered in the European database on medical devices as a manufacturer, with 23 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa23

Among these devices, 23 are declared active.

Authorised representative in the Union: MT-AR-000000234.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED23
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.

Notified body certificates

CertificateStatusExpiry
GB24/00000155issued2029-07-09

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