EU → US Device Access

ABOCA S.P.A. SOCIETÀ AGRICOLA

IT-MF-000029499 · Italy · Sansepolcro (AR)

ABOCA S.P.A. SOCIETÀ AGRICOLA is registered in the European database on medical devices as a manufacturer, with 409 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa242
Class I159
Class IIb8

Among these devices, 7 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 EUDAMED409
Country of registrationItaly
⚠️ 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
EPT 0477.MDR.25/5832issued2028-11-02
EPT 0477.MDR.25/5831issued2030-05-20
EPT 0477.MDR.25/5747issued2028-11-02
EPT 0477.MDR.24/5382issued2028-11-02
EPT 0477.MDR.24/5373issued2028-11-02
EPT 0477.MDR.24/5371issued2028-11-02
EPT 0477.MDR.24/5370.2reissued2028-11-02
EPT 0477.MDR.23/5276.4reissued2028-11-02

Other manufacturers in Italy

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