Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
TürkiyeFDA applicant, unverified FDA FEI 3013659050
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi makes
Medcare Saglik Urunleri produces sterile triplex surgical gowns in sizes small through extra extra large, designed for single-use in surgical and procedural settings.
The company’s triplex 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 US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3013659050
- Address
- Fatih Mah. Camlik Cad no 54, Izmir
Frequently asked questions
How many devices does Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi have in the registry?
The registry currently lists 1 device for Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi's devices?
Among its 1 most recently registered device, Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi has devices listed in FDA 510(k) (1 device).
What risk classes do Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi's devices fall under?
Among its 1 most recently registered device, the classes recorded for Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi in the registry?
The most recently registered devices listed for Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi include Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL).