EU → North America 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: 1 mL syringe based on cross-linked sodium hyaluronate, 2 mL syringe based on 1,2% sodium hyaluronate medium molecular weight , 2 mL syringe based on high molecular weight hyaluronic acid, 2 mL syringe based on high molecular weight hyaluronic acid and niacin, 2 mL syringe based on medium molecular weight hyaluronic acid.

Among these devices, 48 are declared sterile, 48 implantable.

Devices declared under this manufacturer

Showing 12 of 48 declared devices.

Catalogue references include DIV02V, INN03, INN104, INN110, INN30, ROS06V.

European nomenclature codes declared: P900402.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED48
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 GTIN48
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. Innate s.r.l. was not found in either the U.S. or the Canadian register.

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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