EU → US 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 hypertonic ointment with sodium hyaluronate 0,4%, Ophthalmic isotonic ointment with sodium hyaluronate 0.4%, Ophtalmic gel with dexpanthenol, OPHTHALMIC SOLUTION WITH CMC 0,5% - 1% Preservative Free.

Among these devices, 31 are declared sterile.

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 EUDAMED31
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
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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