HyProCure Sinus Tarsi Instrument Set
by Graham Medical Technologies, LLC EUDAMED
Active
Ref HYP-INS-TRAY, CP15-05-FG, CP15-06-FG, CP15-07-FG, CP15-08-FG, CP15-09-FG, CP15-10-FG, HD-5-FG, HYP-GuideWires ,,Model 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- Withdrawn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
- Model / Reference
- HYP-INS-Tray, CP15-05-FG, CP15-06-FG, CP15-07-FG, CP15-08-FG, CP15-09-FG, CP15-10-FG, HD-5-FG, HYP-GuideWires
- Primary DI / UDI-DI
- +M621HYPINSTRAY0
- Basic UDI-DI
- ++M621HYPINSTRAYPN
- Direct Marketing DI
- +M621HYPINSTRAY0
- 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