Oruflow
by Oruba Medikal Teknoloji Arge Ic Ve Dis Ticaret Anonim Sirketi Türkiye EUDAMED
Ref Oruflow h , Oruflow i EMG, Oruflow h EMG, Oruflow-i, Oruflow i ProModel Oruflow-i, Oruflow i Pro, Oruflow i EMG, Oruflow h, Oruflow h Pro, Oruflow h EMG
EMDN Z121605
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2975-MED-2600701 | Date7 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2975-MED-2600701 Issued
Quality management system EU MDR
- Notified body
- Notified body 2975
- Issued
- 7 Jan 2026
- Expires
- 6 Jan 2031
Specification
- Device Name
- Oruflow Self Operating Uroflowmete
- Model / Reference
- Oruflow-i, Oruflow i Pro, Oruflow i EMG, Oruflow h, Oruflow h Pro, Oruflow h EMG
- Primary DI / UDI-DI
- 86819860493620, 86819860493316, 86819860493866, 86819860493170, 86819860493248
- Basic UDI-DI
- 86819860493oruflow9J
- Direct Marketing DI
- 8681986049362086819860493316868198604938668681986049317086819860493248
- EMDN Code
- Z121605 Uroflowmeters
- Device Class
- Class IIa
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000035579
Other devices from Oruba Medikal Teknoloji Arge Ic Ve Dis Ticaret Anonim Sirketi
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (5)
- EUDAMED d7d0c0c9-3ebd-49d8-82a8-adba85a87a03
- EUDAMED 86819860493316|86819860493ORUFLOW9J
- EUDAMED 86819860493866|86819860493ORUFLOW9J
- EUDAMED 86819860493170|86819860493ORUFLOW9J
- EUDAMED 86819860493248|86819860493ORUFLOW9J