Data / Medical devices / Slovakia / Chirana T.injecta, A.S.
Chirana T.injecta, A.S.: FDA-registered device maker in Stara Tura Trenciansky, Slovakia, 4 510(k) clearances
Chirana T.injecta, A.S. is registered with the FDA (registration 3008272066) in Stara Tura Trenciansky, Slovakia. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008272066
- Address
- Nam. Dr. A.Schweitzera 194, Stara Tura Trenciansky, Slovakia, 916 01
- Owner or operator
- CHIRANA T.Injecta, a.s. (10046566)
- Roles
- Manufacturer
- First device listed
- October 25, 2024
- Registered through
- 2026
- Brand names listed
- Blood Collection Needles, Insulin Syringe, Insulin Syringes, MEDOJECT fine Pen Needles, ONE-CARE Insulin syringes
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 24, 2024 | K242434 | Insulin Syringes | FMF | Substantially Equivalent | Chirana T. Injecta | accessdata.fda.gov |
| June 15, 2022 | K220614 | MEDOJECT fine Pen Needles | FMI | Substantially Equivalent | Chirana T. Injecta | accessdata.fda.gov |
| January 18, 2022 | K201044 | CHIRANA Insulin Syringes | FMF | Substantially Equivalent | Chirana T. Injecta | accessdata.fda.gov |
| July 21, 2021 | K201009 | CHIRAVAC Blood Collection Needles | JKA | Substantially Equivalent | Chirana T. Injecta | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Syringe, Piston
Updated December 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.