SIS Medical AG
CH-MF-000015821 · Switzerland · Frauenfeld
SIS Medical AG is registered in the European database on medical devices as a manufacturer, with 68 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 68 |
|---|
Among these devices, 68 are declared sterile.
Authorised representative in the Union: EUMEDIQ GmbH.
Devices declared under this manufacturer
- EasyT
- NIC 1.1 hydro
- NIC Nano hydro
- OPN NC
Showing 12 of 68 declared devices.
Catalogue references include 150-015-004, 200-015-004, 250-010-134, 250-015-134, 250-030-134, 300-010-004.
European nomenclature codes declared: C010401020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SIS MEDICAL AG (CH) · FDA 3013634084 |
| Devices in EUDAMED | 68 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 68 |
|---|---|
| Found in the U.S. device database | 21 |
| Share | 30.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SIS MEDICAL AG |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 4 devices | 1 |
| First licensed | 2024-11-13 |
Licence types: Device Family (1).
Licensed under: OPN NC SUPER HIGH PRESSURE PTCA DILATATION CAT.
North American profile: Both markets. SIS Medical AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
44912221715 | amended | 2030-02-27 |
44911221715 | supplemented | 2030-02-27 |