EU → US Device Access

Vircell, S.L

ES-MF-000004099 · Spain · Granada

Vircell, S.L is registered in the European database on medical devices as a manufacturer, with 157 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

other157

Most frequent device types declared: TM, TM2, S001, RTPCR021, MBC039.

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 EUDAMED157
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
V76 112727 0006issued2031-02-22
V13 112727 0005supplemented2027-10-17

Other manufacturers in Spain

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