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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 I159
Class IIa242
Class IIb8

Among these devices, 7 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 409 declared devices.

Catalogue references include 08032472006831, 08032472009320, 08032472013266, 08032472016656, 08032472027997, 08032472031741.

European nomenclature codes declared: V9017, G0401, Q030199, Q0299, M9002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED409
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN384
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. ABOCA S.P.A. SOCIETÀ AGRICOLA was not found in either the U.S. or the Canadian register.

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

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