Strp, SFL, 10.5in, AJT, DA, Upr Rec, A, SS, HP
by Becker Orthopedic Appliance Company
Ref W2950-A10.5-1, W2950-A10.5-2, W2950-A10.5-3, W2950-A10.5Model Double Action Ankle Components
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number194545DBLACTANKLE86 | Date13 Jan 2022 | 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- Withdrawn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
- Trade Name
- Strp, SFL, 10.5in, AJT, DA, Upr Rec, A, SS, HPStrp, SFL, 10.5in, AJT, DA, Upr Rec, A, SS, SlSpStrp, SFL, 10.5in, AJT, DA, Upr Rec, A, SS, SlPStrp, SFL, 10.5in, AJT, DA, Upr Rec, A, SS, HSp
- Device Name
- Double Action Ankle Components
- Model / Reference
- Double Action Ankle Components, W2950-A10.5-1, W2950-A10.5-2, W2950-A10.5-3, W2950-A10.5
- Primary DI / UDI-DI
- 00194545041618, 00194545041625, 00194545041632, 00194545041601
- Basic UDI-DI
- 194545DBLACTANKLE86
- EMDN Code
- Y06120602 Energy return ankle-foot orthoses
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000004002
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Becker Orthopedic Appliance Company
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