EU → US Device Access

Lombard Medical Limited

GB-MF-000014515 · United Kingdom · Didcot

Lombard Medical Limited is registered in the European database on medical devices as a manufacturer, with 1 000 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I1 000

Most frequent device types declared: 01-AA-24-090.

Among these devices, 1 000 are declared sterile, 1 000 implantable.

Authorised representative in the Union: IE-AR-000002496.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 000
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
170781685issued2028-12-20
170781682issued2028-12-20
1000170426issued2029-09-04

Other manufacturers in United Kingdom

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