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 – German Market (Shiseido), GO-ON Medical Device- Austria (HTL), GO-ON Medical Device- Austria (Shiseido), GO-ON Medical Device– Baltic Markets (Estonia, Lithuania, Latvia) - Sh, GO-ON Medical Device– Belgian Market (Shiseido).
Among these devices, 18 are declared sterile, 18 implantable.
Devices declared under this manufacturer
- GO-ON
- GO-ON Medical Device – German Market (Shiseido)
- GO-ON Medical Device- Austria (HTL)
- GO-ON Medical Device- Austria (Shiseido)
- GO-ON Medical Device– Baltic Markets (Estonia, Lithuania, Latvia) (HTL
- GO-ON Medical Device– Baltic Markets (Estonia, Lithuania, Latvia) - Sh
- GO-ON Medical Device– Belgian Market (Shiseido)
- GO-ON Medical Device– French Market (HTL)
- GO-ON Medical Device– French Market (Shiseido)
- GO-ON Medical Device– Italy (HTL)
- GO-ON Medical Device– Italy (Shiseido)
- GO-ON Medical Device– Portuguese Market (Shiseido)
Showing 12 of 18 declared devices.
Catalogue references include 70216, 70267, 70638, 70694, 70695, 70699.
European nomenclature codes declared: A02010799.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| Country of registration | Ireland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 18 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ROTTAPHARM LTD. |
North American profile: Canada only. Rottapharm Ltd holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 038830 0035 | issued | 2031-06-30 |