Carbon AFO
by Orthotech Rehabilitation Co., Ltd. EUDAMED
Active
Ref 626301(S/Right/Black)Model AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number47199644662WL | Date14 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ankle Brace, Ankle Foot Orthosis, Night Splint (Ankle/foot orthosis)
- Model / Reference
- AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016, 626301(S/Right/Black)
- Primary DI / UDI-DI
- 04719964469766
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000051924
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247