Data / Medical devices / Turkey / Medcare Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi
Medcare Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi: FDA-registered device maker in Izmir, Turkey, 1 510(k) clearance
Medcare Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi is registered with the FDA (registration 3013659050) in Izmir, Turkey. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 16, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013659050
- Address
- Fatih Mah. Camlik Cad no 54, Izmir, Turkey, 35410
- Owner or operator
- MEDCARE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (10074646)
- Roles
- Manufacturer
- First device listed
- May 28, 2020
- Registered through
- 2026
- Brand names listed
- Medcare Healthcare Underpad, Medcarehealthcare Adult Diapers Slip (Classic, Premium, Maxi) (S-M-L-XL), Medcarehealthcare Adult Pants (Classic, Maxi) (S-M-L-XL), Medcarehealthcare Underpad (Economic Normal Plus) (60x40 cm - 60x60 cm 60x90 cm 80x180 cm 90x180 cm), Metset Adult Diapers Slip (Standard) (S-M-L-XL), Metset Adult Pants (Standard) (S-M-L-XL), Non-Surgical Gown, Sterile Triplex Surgical Gown (S-M-L-XL-XXL-XXXL)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Mattress (Medical Purposes) | FMW | 1 | Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | 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 |
|---|---|---|---|---|---|---|
| August 16, 2023 | K230577 | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | FYA | Substantially Equivalent | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Surgical Gown
- All makers of Garment, Protective, For Incontinence
- All makers of Cover, Mattress (Medical Purposes)
- All makers of Gown, Surgical
Updated August 16, 2023. 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.