EU → North America Device Access

Medico Srl

IT-MF-000016800 · Italy · PADOVA

Medico Srl is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1
Class I11

Most frequent device types declared: ERIS SR, ERIS VDR, ERMES_PLUS, Hera DR, Iris DR MRI.

Among these devices, 11 are declared sterile, 11 implantable, 12 active.

Devices declared under this manufacturer

Catalogue references include ERMES_PLUS, PMERISSRM, PMERISVDR, PMIRISDRM, PMIRISRM, PMIRISVDDM.

European nomenclature codes declared: J01010302, J01010202, J01010102, Z12050899, J01010401.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
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 GTIN12
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. Medico Srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
291/MDRissued2029-02-28
155/MDRsupplemented2029-02-28

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