AJT, DFA, Anodized Alum Upr, 3/16x1/2 LL/RM HPin
by Becker Orthopedic Appliance Company United States EUDAMED
Ref AX3245-AL-1Model Dorsi Assist Ankle Components
EMDN Y06120602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number194545DORSIANKLEBN | Date20 Jan 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dorsi Assist Ankle Components
- Model / Reference
- Dorsi Assist Ankle Components, AX3245-AL-1
- Primary DI / UDI-DI
- 00194545022358
- Basic UDI-DI
- 194545DORSIANKLEBN
- EMDN Code
- Y06120602 Energy return ankle-foot orthoses
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000004002
- Authorised representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Other devices from Becker Orthopedic Appliance Company
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 625ab611-ac3d-42d9-a7db-3edc9192ec0c