EU → US Device Access

Celsius Medical S.L.

ES-MF-000006604 · Spain · Ajalvir

Celsius Medical S.L. is registered in the European database on medical devices as a manufacturer, with 68 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa52
Class IIb16

Most frequent device types declared: CNOCL1, CSOCA1, CCALIMA22S, CCALIMA12S, CCALIMA221S.

Among these devices, 25 are declared sterile, 16 active.

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 EUDAMED68
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
ES25/00001195issued2030-11-17

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