ALX Cover Small Black
by Koalaa Ltd United Kingdom EUDAMED
Ref KA9Model ALX
EMDN Y061809
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506108178ALXBE4X | Date29 Nov 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Alx Below Elbow Prosthesis
- Model / Reference
- ALX, KA9
- Primary DI / UDI-DI
- 05061081780088
- Basic UDI-DI
- 506108178ALXBE4X
- Direct Marketing DI
- 05061081780088
- EMDN Code
- Y061809 Transradial prostheses (for amputation under elbow)
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- UK-MF-000045260
- Authorised representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Other devices from Koalaa
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 (1)
- EUDAMED 20612f2e-663d-4437-96e4-e2d0ffb03ad0