EU → US Device Access

Iberhospitex, S.A.

ES-MF-000000160 · Spain · Lliçà de Vall

Iberhospitex, S.A. is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I46
Class IIa14

Among these devices, 52 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 EUDAMED60
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
ES22/00000630amended2027-10-10
2025 CR 0045issued2029-07-01
2024 PR 0030issued2029-07-01

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