Bayteks Teknik Tekstil San. VE Tic. A.S.
TürkiyeFDA applicant, unverified
- Devices
- 1
What Bayteks Teknik Tekstil San. VE Tic. A.S. makes
Bayteks Teknik Tekstil San. VE Tic. A.S. manufactures surgical gowns designed for single-use in clinical settings to provide barrier protection during medical procedures.
The company’s surgical gowns are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Surgical Gown Ref K213844
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bayteks Teknik Tekstil San. VE Tic. A.S. have in the registry?
The registry currently lists 1 device for Bayteks Teknik Tekstil San. VE Tic. A.S.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bayteks Teknik Tekstil San. VE Tic. A.S.'s devices?
Among its 1 most recently registered device, Bayteks Teknik Tekstil San. VE Tic. A.S. has devices listed in FDA 510(k) (1 device).
What risk classes do Bayteks Teknik Tekstil San. VE Tic. A.S.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bayteks Teknik Tekstil San. VE Tic. A.S.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bayteks Teknik Tekstil San. VE Tic. A.S. in the registry?
The most recently registered devices listed for Bayteks Teknik Tekstil San. VE Tic. A.S. include Surgical Gown.