EU → US Device Access

Tecnoclínic SA

ES-MF-000000632 · Spain · Sabadell (Barcelona)

Tecnoclínic SA is registered in the European database on medical devices as a manufacturer, with 84 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa84

Most frequent device types declared: 29440 - A0304, A0369, A0349, A0370, A0318.

Among these devices, 21 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED84
Country of registrationSpain
⚠️ 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
CGP000124issued2029-04-15

Other manufacturers in Spain

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