Pro-Flex® Terra
by Össur Iceland ehf. 924 variants
Ref PTA0427LBRModel BU00046
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The Pro-Flex Terra device is a cutting-edge orthopedic implant designed to provide superior stability and support for patients with severe ankle instability. With its unique patented design and advanced materials, this device offers unparalleled performance and user experience.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00046NH 05690977727502 | Date27 May 2026 | 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- Withdrawn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
- Model / Reference
- BU00046, PTA0427LBR
- Primary DI / UDI-DI
- 05690977727502
- Basic UDI-DI
- 5690967BU00046NH
- EMDN Code
- Y062403 Foot partial prostheses (including toe prostheses)
- Device Class
- Class I
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IS-MF-000000173
Other devices from Össur Iceland ehf.
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