Rontis Corporation SA
CH-MF-000031411 · Switzerland · Zug
Rontis Corporation SA is registered in the European database on medical devices as a manufacturer, with 443 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 440 |
|---|---|
| Class IIa | 3 |
Most frequent device types declared: EL20/20, EL25/25, EL27/10, EL45/20, Europa Ultra™ Family.
Among these devices, 443 are declared sterile.
Authorised representative in the Union: RONTIS HELLAS MEDICAL AND PHARMACEUTICAL PRODUCTS S.A..
Devices declared under this manufacturer
- Europa Ultra™
- InRo®
Showing 12 of 443 declared devices.
Catalogue references include EL20/20, EL27/10, EL30/20, EL45/15, EO15/15, IN27/25.
European nomenclature codes declared: C010401020101, V028099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 443 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 443 |
|---|---|
| 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. Rontis Corporation SA was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44912221174 | issued | 2029-03-14 |
44911221174 | issued | 2029-03-14 |