EU → North America Device Access

NTC Srl

IT-MF-000026977 · Italy · Milan

NTC Srl is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb31

Most frequent device types declared: OPHTHALMIC SOLUTION WITH CMC 0,5% - 1% Preservative Free, Ophtalmic gel with dexpanthenol, Ophtalmic solution with sodium hyaluronate 0,1% - 0,2%, 0,4% - preserv, Ophthalmic hypertonic ointment with sodium hyaluronate 0,4%, Ophthalmic isotonic ointment with sodium hyaluronate 0.4%.

Among these devices, 31 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 31 declared devices.

Catalogue references include DEX042, HAO057, HAO058, HAO067, HAO072, HYS277.

European nomenclature codes declared: Q02030301, Q02030399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED31
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 GTIN31
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. NTC Srl was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
086-00-00-MDRissued2030-11-10
075-00-00-MDRwithdrawn2030-05-04
066-00-00-MDRwithdrawn2030-01-13
058-00-01-MDRwithdrawn2029-09-19
050-00-00-MDRwithdrawn2026-06-09
046-00-00-MDRwithdrawn2029-05-07
040-00-00-MDRwithdrawn2029-02-08
038-00-02-MDRwithdrawn2029-01-23

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