Data / Medical devices / Turkey / Elde Medikal Sanayi Ve Ticaret Anonim Sirketi
Elde Medikal Sanayi Ve Ticaret Anonim Sirketi: FDA-registered device maker in Umraniye Istanbul, Turkey, 1 510(k) clearance
Elde Medikal Sanayi Ve Ticaret Anonim Sirketi is registered with the FDA (registration 3046649655) in Umraniye Istanbul, Turkey. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 8, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3046649655
- Address
- Necip Fazil Bulvari Keyap Carsi Sitesi No: 44 D-1 Blok Dukkan No: 53/2, Umraniye Istanbul, Turkey, 34775
- Owner or operator
- ELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI (10096133)
- Roles
- Manufacturer
- First device listed
- July 6, 2026
- Registered through
- 2026
- Brand names listed
- Elde Medical Electrodes Model: ELDT5/T5, Elde Medical Electrodes Model: ELDT10/T10
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 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 |
|---|---|---|---|---|---|---|
| May 8, 2026 | K253237 | Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) | GXY | Substantially Equivalent | Elde Medikal Sanayi ve Ticaret Anonim Sirketi | accessdata.fda.gov |
Compare with other makers
Updated May 8, 2026. 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.