Rottapharm Ltd
IE-MF-000005490 · Ireland · Dublin
Rottapharm Ltd is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 18 |
|---|
Most frequent device types declared: GO-ON Medical Device- Austria (HTL), GO-ON Medical Device– French Market (HTL), GO-ON Medical Device– French Market (Shiseido), GO-ON Medical Device– Belgian Market (Shiseido), GO-ON Medical Device- Austria (Shiseido).
Among these devices, 18 are declared sterile, 18 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 | 18 |
| Country of registration | Ireland |
⚠️ 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
| Certificate | Status | Expiry |
|---|---|---|
G15 038830 0035 | issued | 2031-06-30 |