Foot-Bunion Separator
by e-life International Co., Ltd. 3 variants
Ref MTS0014 (L/XL/UNI/WH)Model Toe Separator Series
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
A reliable and effective foot-bunion separator device designed to provide a safe and efficient solution for patients suffering from bunions. Our product features advanced technology and precision engineering, ensuring accurate separation of the bony prominence from the surrounding tissue. By utilizing our device, healthcare professionals can minimize discomfort and optimize recovery times.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number471230298TSS9 04712302984464 | Date30 Apr 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- Withdrawn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
- Toe separator
- Model / Reference
- Toe Separator Series, MTS0014 (L/XL/UNI/WH)
- Primary DI / UDI-DI
- 04712302984464
- Basic UDI-DI
- 471230298TSS9
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- EU 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
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