GaitMate
by e-life International Co., Ltd. Taiwan EUDAMED
Ref MCA0004 (L/UNI/BK)Model Cast Boot Series
EMDN Y0699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471230298CAPJ | Date30 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Cast shoe
- Model / Reference
- Cast Boot Series, MCA0004 (L/UNI/BK)
- Primary DI / UDI-DI
- 04719894926544
- Basic UDI-DI
- 471230298CAPJ
- EMDN Code
- Y0699 External prostheses and orthoses - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- TW-MF-000009901
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from e-life International Co., Ltd.
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 04719894926544|471230298CAPJ