CHIRANA T.Injecta, a.s.
SK-MF-000003702 · Slovakia · Stará Turá
CHIRANA T.Injecta, a.s. is registered in the European database on medical devices as a manufacturer, with 97 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 96 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: Hypodermic syringe, Blood collection needle, Hypodermic needle, Insulin pen needle, Sterile injection set.
Among these devices, 86 are declared sterile.
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 | Registered with FDA |
|---|---|
| Matched entry | CHIRANA T.INJECTA, A.S. (SK) · FDA 3008272066 |
| Devices in EUDAMED | 97 |
| Country of registration | Slovakia |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2024-MDR/QS-071 | issued | 2027-09-30 |
2022-MDR/QS-027/A | supplemented | 2027-09-30 |
2022-MDR/QS-026/D | supplemented | 2027-09-30 |
2022-MDR/QS-025/E | supplemented | 2027-09-30 |
2022-MDR/QS-024/B | supplemented | 2027-09-30 |