Ufr
by Shanghai Pulse Medical Technology, Inc. China EUDAMED
Ref NAModel IvusPlus 1.0, IvusPlus
EMDN Z129092
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-16974687731513 | Date12 Oct 2024 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- IvusPlusIVUS-Derived Fractional Flow Reserve Analysis Software
- Model / Reference
- IvusPlus 1.0, NA, IvusPlus
- Primary DI / UDI-DI
- 16974687731513, 06974687731516
- Basic UDI-DI
- B-16974687731513, 697468773IVUS015Z
- Direct Marketing DI
- 06974687731516
- EMDN Code
- Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
- Device Class
- Class IIa
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000033837
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shanghai Pulse Medical Technology, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED 8b5716a9-ae9a-4962-9820-ffc7a8f05fad
- EUDAMED 06974687731516|697468773IVUS015Z