ASole-RunWalk insole-Red-XL
Ref 61135Model RunWalk insole, GolfSki insole,BikeFit insole,BestFit-ESD insole, WorkFit insole,Pressure relief insole
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 | Number471987147MDinsoleK6 04719871473979 | Date5 Dec 2025 | 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- Withdrawn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
- Orthotic Insoles.
- Model / Reference
- RunWalk insole, GolfSki insole, BikeFit insole, BestFit-ESD insole, WorkFit insole, Pressure relief insole, 61135
- Primary DI / UDI-DI
- 04719871473979
- Basic UDI-DI
- 471987147MDinsoleK6
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000048502
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Global Action Inc
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