GRAIL with 250cm high projection screen
Ref SY020Model GRAIL
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 | Number87193268410GRAILAL 08720938314223 | Date11 Sep 2026 | 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- Withdrawn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
- M-Gait System Family
- Model / Reference
- GRAIL, SY020
- Primary DI / UDI-DI
- 08720938314223
- Basic UDI-DI
- 87193268410GRAILAL
- EMDN Code
- Z129006 Treadmills for physiotherapy and/or diagnostic uses
- Device Class
- Class I
- Medical Purpose
- Positive impact on clinical outcomes related to the health of an individual – improvement of impaired body function, specifically leading to improved walking capacity (endurance) Positive impact on clinical outcomes related to the health of an individual – improvement of impaired body function, specifically leading to improved walking ability (walking speed or walking efficiency) Positive impact on clinical outcomes related to the health of an individual – improvement of impaired body function, specifically leading to improved balance ability or balance confidence.
Manufacturer details
- EUDAMED SRN
- NL-PR-000013775
Other devices from Motek Medical B.V.
Properties
Other properties (1)
- Sterile: No