HyProCure Sinus Tarsi Implant
by Graham Medical Technologies, LLC EUDAMED
Active
Ref HYP-05, HYP-06, HYP-07, HYP-08, HYP-09, HYP-10Model HYP-XX
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-++M621HYPXXEP | Date14 Nov 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Device Name
- HyProCure Sinus Tarsi Implant System
- Model / Reference
- HYP-XX, HYP-05, HYP-06, HYP-07, HYP-08, HYP-09, HYP-10
- Primary DI / UDI-DI
- ++M621HYPXXEP
- Basic UDI-DI
- B-++M621HYPXXEP
- EMDN Code
- P090605 Foot endorthesis
- Device Class
- Class IIb
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- US-MF-000008507
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Graham Medical Technologies, LLC
Properties
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No