Bilateral Hip-Knee-Ankle Torsion Splint, 3/8in
by Becker Orthopedic Appliance Company
Ref R-400XModel 400
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 | Number194545400Q3 | Date15 Dec 2021 | 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- Withdrawn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
- Device Name
- Torsions
- Model / Reference
- 400, R-400X
- Primary DI / UDI-DI
- 00194545100209, 90194545100202
- Basic UDI-DI
- 194545400Q3
- EMDN Code
- Y0699 External prostheses and orthoses - other
- Device Class
- Class I
- EU market of registration
- IrelandGermany
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
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