Arayeh
by Arayeh Zisti Pishrafteh EUDAMED
Active
Ref P20-F10Model REVO-6
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number62622386REVO-6M8 | Date19 Feb 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Medical Ultrasound Imaging System
- Model / Reference
- REVO-6, P20-F10
- Primary DI / UDI-DI
- 06262238634806
- Basic UDI-DI
- 62622386REVO-6M8
- EMDN Code
- Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)
- Device Class
- Class IIa
- Market of Registration
- Hungary
Manufacturer details
- EUDAMED SRN
- IR-MF-000052223
- Authorised representative
- Source of Commerce GmbH DE-AR-000050360
Properties
Show properties
Other properties (12)
- 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
- Incorporates Medicinal Product: No