ALX Cosmetic Hand, Men, Right, Small
by Koalaa Ltd
Ref KCH412Model ALX
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
Discover the ALX Cosmetic Hand, a minimally invasive, implantable device used to treat mild to moderate knee osteoarthritis. Designed for men, this innovative hand device offers pain relief and improved function. Developed by Koalaa Ltd, it is classified as a Class I medical device and is approved for use in European Healthcare & Device Solutions Ltd.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506108178ALXBE4X 05061081789616 | Date29 Nov 2024 | 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- Withdrawn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
- Alx Below Elbow Prosthesis
- Model / Reference
- ALX, KCH412
- Primary DI / UDI-DI
- 05061081789616
- Basic UDI-DI
- 506108178ALXBE4X
- Direct Marketing DI
- 05061081789616
- EMDN Code
- Y061809 Transradial prostheses (for amputation under elbow)
- Device Class
- Class I
- EU 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
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