Flex-Foot® Balance
by Össur Iceland ehf. 208 variants
Ref FBPU223LModel BU00049
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
At Flex-Foot Balance, we're proud to offer a revolutionary new solution for patients with foot and ankle issues. Our cutting-edge device is designed to provide unparalleled stability and support, allowing individuals to regain their independence and confidence. With its sleek design and advanced technology, this product has been carefully crafted to meet the specific needs of our target market.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00049NP 05690977398979 | 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- Withdrawn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
- BU00049, FBPU223L
- Primary DI / UDI-DI
- 05690977398979
- Basic UDI-DI
- 5690967BU00049NP
- 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