Forearm Crutch
Ref AW FC C1.00Model Basic 100
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 | Number385889357AWFCC1.00NK | 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- Withdrawn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
- Forearm Crutch
- Model / Reference
- Basic 100, AW FC C1.00
- Primary DI / UDI-DI
- 03858893571117, 03858893571100, 03858893571155, 03858893571148, 03858893571124
- Basic UDI-DI
- 385889357AWFCC1.00NK
- Direct Marketing DI
- 0385889357111703858893571100038588935711550385889357114803858893571124
- EMDN Code
- Y120380 One arm manipulated walking aids - accessories
- 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