Carbon AFO
by Orthotech Rehabilitation Co., Ltd. China EUDAMED
Ref 626301(M/Right/Black)Model AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016 EMDN Y06120601
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- Withdrawn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(M/Right/Black)
- Primary DI / UDI-DI
- 04719964469773
- Basic UDI-DI
- 47199644662WL
- EMDN Code
- Y06120601 Passive ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000051924
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Orthotech Rehabilitation 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 04719964469773|47199644662WL