Data / Medical devices / Turkey / Biosys Biyomedikal Muhendislik Sanayi Ve Ticaret Anonim Sirketi
Biosys Biyomedikal Muhendislik Sanayi Ve Ticaret Anonim Sirketi: FDA-registered device maker in Cankaya Ankara, Turkey, 1 510(k) clearance
Biosys Biyomedikal Muhendislik Sanayi Ve Ticaret Anonim Sirketi is registered with the FDA (registration 3031550429) in Cankaya Ankara, Turkey. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 13, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3031550429
- Address
- Universiteler Mah. Ihsan Dogramaci Blv. Satgeb No:23 C, Cankaya Ankara, Turkey, 06800
- Owner or operator
- BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRK (10093622)
- Roles
- Manufacturer
- First device listed
- June 13, 2025
- Registered through
- 2026
- Brand names listed
- Bioscope Neuromonitor Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve | ETN | 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 13, 2024 | K233001 | Bioscope Neuromonitor Device | ETN | Substantially Equivalent | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | accessdata.fda.gov |
Compare with other makers
Updated December 13, 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.