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 IIb | 31 |
|---|
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
- Blupan Protect
- Ceramol ofta repair
- Edenight
- HYAL 0.2%
- Helenvision Balance
- Helenvision Pure
- Hyal plus 0.4%
- Ocusalin night
- Proluxx Duo
- Proluxx Edenight
- Proluxx Night
- Puro Protect
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 register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 31 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not 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
| Certificate | Status | Expiry |
|---|---|---|
086-00-00-MDR | issued | 2030-11-10 |
075-00-00-MDR | withdrawn | 2030-05-04 |
066-00-00-MDR | withdrawn | 2030-01-13 |
058-00-01-MDR | withdrawn | 2029-09-19 |
050-00-00-MDR | withdrawn | 2026-06-09 |
046-00-00-MDR | withdrawn | 2029-05-07 |
040-00-00-MDR | withdrawn | 2029-02-08 |
038-00-02-MDR | withdrawn | 2029-01-23 |