AERAZEN LAB SRL
IT-MF-000028400 · Italy · MILANO
AERAZEN LAB SRL is registered in the European database on medical devices as a manufacturer, with 47 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 47 |
|---|
Most frequent device types declared: SYRINGE OF 2 ML, SYRINGE OF 1 ML - 2.6% HA (FILLER EXTRA STRONG), SYRINGE OF 10 ML - 2% HA (FILLER LARGE VOLUME), SYRINGE OF 1 ML - 2.4% HA (FILLER STRONG), SYRINGE OF 4 ML.
Among these devices, 47 are declared sterile, 47 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 register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 47 |
| Country of registration | Italy |
⚠️ 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.