Toe Ring
by Orthotech Rehabilitation Co., Ltd. 3 variants
Part of a family of 30 devices: see the family page
Ref 650005(M/UNI/White)
Toe Ring (650005(M/UNI/White)) is a Class I device made by Orthotech Rehabilitation Co., Ltd., registered in EUDAMED on 24 Apr 2026 (Basic UDI-DI 47199644665WS), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number47199644665WS 04719964461654 | Date24 Apr 2026 | StatusActive |
Official records
- EUDAMED public site 47199644665WS
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- Withdrawn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
- Insole (Hallux valgus metatarsophalangeal orthosis and toe separator)
- Model / reference
- 650005(M/UNI/White)
- Primary DI / UDI-DI
- 04719964461654
- Basic UDI-DI
- 47199644665WS
- EMDN code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000051924
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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