EU → US Device Access

OsteoCare Implant System Limited

GB-MF-000016843 · United Kingdom · Colnbrook

OsteoCare Implant System Limited is registered in the European database on medical devices as a manufacturer, with 292 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa164
Class IIb127
Class I1

Most frequent device types declared: Implants, Abutment, Burs, Drivers and Connectors, Reusable Class 1r.

Among these devices, 127 are declared sterile, 198 implantable, 51 reusable.

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

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED292
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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