Data / Medical devices / Turkey / Metko Medikal ve Tibbi Cihazlar Dis Ticaret Sanayi A.S.
Metko Medikal ve Tibbi Cihazlar Dis Ticaret Sanayi A.S.: FDA-registered device maker in Ankara, Turkey, 2 510(k) clearances
Metko Medikal ve Tibbi Cihazlar Dis Ticaret Sanayi A.S. is registered with the FDA (registration 3016088707) in Ankara, Turkey. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 25, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016088707
- Address
- Ivedik O.S.B. Agac Isleri Sanayi Sitesi 1354 Cadde 1358 Sokak No. 9, Ankara, Turkey, 06378
- Owner or operator
- Metko Medikal ve Tibbi Cihazlar Dis Ticaret Sanayi A.S. (10073725)
- Roles
- Manufacturer
- First device listed
- May 13, 2020
- Registered through
- 2026
- Brand names listed
- Cable, Electrode (ECG-EKG) cables and LeadWires, E100/ARB/A, E100/ARB/I, E100/ARG/A, E100/ARG/I, E100/ARS/A, E100/ARS/I, E100/BNB/A and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 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 |
|---|---|---|---|---|---|---|
| October 25, 2024 | K240223 | FMT Disposable and Autoclavable Temperature Probes | FLL | Substantially Equivalent | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | accessdata.fda.gov |
| July 18, 2023 | K213100 | FMT Reusable Temperature Probes | FLL | Substantially Equivalent | Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti | accessdata.fda.gov |
Compare with other makers
Updated October 25, 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.