HyProCure Sizer 10
by Graham Medical Technologies, LLC EUDAMED
Active
Ref CP-15-10-FGModel HYP-INS-Tray
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++M621HYPINSTRAYPN | Date21 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- HyProCure Sinus Tarsi Instrument Set
- Model / Reference
- HYP-INS-Tray, CP-15-10-FG
- Primary DI / UDI-DI
- +M621CP1510FG0
- Basic UDI-DI
- ++M621HYPINSTRAYPN
- EMDN Code
- L0999 Orthopaedic and traumatological surgery instruments, reusable - other
- Device Class
- Class I
- Market of Registration
- Austria
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 (12)
- Sterile: No
- Implantable: 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