EU → US Device Access

i+Med S.Coop.

ES-MF-000008633 · Spain · Vitoria-Gasteiz

i+Med S.Coop. is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I24
Class IIa22
Class IIb8

Most frequent device types declared: OpHLINE 1.4%, OpHLINE 2.0%, OpHLINE 3.0%, TrHCROSS 2.0%, DayDrop 30ud x 0.4ml.

Among these devices, 35 are declared sterile, 27 implantable.

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 EUDAMED54
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
2026 DR 0071issued2029-06-26
2024 CR 0029issued2029-06-26

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