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: Bed cover, Blood collection needle, Blood collection needle holder, Filter, Hypodermic syringe.
Among these devices, 86 are declared sterile.
Devices declared under this manufacturer
- CHIRAFLEX 22G
- CHIRANA 10ml Luer 2-part
- CHIRANA 1ml Luer U100
- CHIRANA 2ml Luer 2-part
- CHIRANA 50ml Luer-Lock 3-part Opaque
- CHIRAPLUS Injection port
- CHIRAVAC quick release
- CPE Bed cover blue
- ECOJECT 10ml Luer 2-part
- ECOJECT 2ml Luer 2-part
- MEDOJECT FINE 0,33x12,7mm (29G)
- PAPER BED SHEET ROLL width 40cm
Showing 12 of 97 declared devices.
Catalogue references include 20010, AP02-001-00/CH, CH010L, CH03050LLO, CH700040, CHBC01.
European nomenclature codes declared: A01010502, A020102020102, A020102010202, A020102010102, A0101010102, A0101010202.
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 |
Device-level evidence
| Devices with a numeric GTIN | 97 |
|---|---|
| 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: United States only. CHIRANA T.Injecta, a.s. is registered in the United States but was not found in the Canadian register.
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 |