EU → US Device Access

Innate s.r.l.

IT-MF-000026730 · Italy · Novi Ligure

Innate s.r.l. is registered in the European database on medical devices as a manufacturer, with 48 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I48

Most frequent device types declared: 2 mL syringe based on sodium hyaluronate and trehalose, Promovia Family, Playal 80, 2 mL syringe based on medium molecular weight hyaluronic acid, 2 mL syringe based on high molecular weight hyaluronic acid.

Among these devices, 48 are declared sterile, 48 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 EUDAMED48
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.25/5697issued2027-07-31
EPT 0477.MDR.25/5696issued2027-07-31
EPT 0477.MDR.24/5690.1reissued2027-07-31
EPT 0477.MDR.24/5689.1reissued2027-07-31
EPT 0477.MDR.22/4901.4reissued2027-07-31
064-00-01-MDRissued2029-11-13
063-00-00-MDRissued2029-11-13

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