Data / Medical devices / Turkey / Set Medikal Sanayi Ve Ticaret Anonim Sirketi
Set Medikal Sanayi Ve Ticaret Anonim Sirketi: FDA-registered device maker in esenyurt Istanbul, Turkey, 2 510(k) clearances
Set Medikal Sanayi Ve Ticaret Anonim Sirketi is registered with the FDA (registration 3017907716) in esenyurt Istanbul, Turkey. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 14, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017907716
- Address
- Osmangazi Mahallesi Maresal Fevzi Cakmak Caddesi No.18 Esenyurt, esenyurt Istanbul, Turkey, 34522
- Owner or operator
- Set Medikal Sanayi Ve Ticaret Anonim Sirketi (10079852)
- Roles
- Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- December 29, 2020
- Registered through
- 2026
- Brand names listed
- Occlutech® ASD Occluder, Occlutech® Pistol Pusher, Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer- lock, Sterile Hypodermic Syringe for Single use, with/without needle; luer/luer-lock, Sterile Hypodermic needle for Single use, Sterile Insulin Syringe for Single use, with needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Transcatheter Septal Occluder (Atrial) | OZG | 3 | Contract sterilizer | 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 |
|---|---|---|---|---|---|---|
| May 14, 2021 | K210200 | 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock | FMF | Substantially Equivalent | Set Medikal Sanayi VE Ticaret Anonim Sirketi | accessdata.fda.gov |
| December 14, 2020 | K201284 | Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use | FMF | Substantially Equivalent | Set Medikal Sanayi VE Ticaret Anonim Sirketi | accessdata.fda.gov |
Compare with other makers
- All makers of Transcatheter Septal Occluder (Atrial)
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Irrigating (Non Dental)
Updated May 14, 2021. 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.