Pro-Flex® Modular
by Össur Iceland ehf. 396 variants
Ref PMD0123RBRModel BU00046
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
Introducing the Pro-Flex Modular, a cutting-edge medical device designed for precise and accurate measurements in various clinical settings. Made by Össur Iceland ehf., this modular device is equipped with advanced technology to provide reliable results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5690967BU00046NH 05690977243835 | 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- Withdrawn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, PMD0123RBR
- Primary DI / UDI-DI
- 05690977243835
- 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