Data / Medical devices / Turkey / Dort-A Tip Malz San Ith Ihr Tic Ltd Sti
Dort-A Tip Malz San Ith Ihr Tic Ltd Sti: FDA-registered device maker in Ankara, Turkey, 1 510(k) clearance
Dort-A Tip Malz San Ith Ihr Tic Ltd Sti is registered with the FDA (registration 3031982553) in Ankara, Turkey. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 12, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3031982553
- Address
- Balikhisar Mah Koyici Serpmeleri No:795/A Akyurt, Ankara, Turkey, 06750
- Owner or operator
- DORT-A TIP MALZ SAN ITH IHR TIC LTD STI (10091243)
- Roles
- Manufacturer
- First device listed
- July 31, 2024
- Registered through
- 2026
- Brand names listed
- EO Chex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | 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 |
|---|---|---|---|---|---|---|
| June 12, 2024 | K240910 | EO Chex Indicator Tape | JOJ | Substantially Equivalent | Propper Manufacturing Co., Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 12, 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.