Rollator
by Awatar Medical Aid d.o.o. 3 variants
Ref AW RAL4W X5.002Model Ikki 500
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number385889357AWRAL4WX5.002S9 03858893570905 | Date19 Jul 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Rollator
- Model / Reference
- Ikki 500, AW RAL4W X5.002
- Primary DI / UDI-DI
- 03858893570905
- Basic UDI-DI
- 385889357AWRAL4WX5.002S9
- Direct Marketing DI
- 03858893570905
- EMDN Code
- Y120606 Wheeled walker
- Device Class
- Class I
- EU market of registration
- Croatia
Manufacturer details
- EUDAMED SRN
- HR-MF-000025777
Other devices from Awatar Medical Aid d.o.o.
Properties
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