Oxyworld
by Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇ 48 variants
Ref OXW1500
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-8683181925199BR D-8683181925199BR | Date20 Oct 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- OXYWORLD Medikal Oksijen Üretim, Depolama ve Denetim Sistemi
- Model / Reference
- OXW1500
- Primary DI / UDI-DI
- D-8683181925199BR
- Basic UDI-DI
- B-8683181925199BR
- EMDN Code
- Z12159004 Oxygen concentrators
- Device Class
- Class IIb
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000037182
Other devices from Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No