Foxtrot Nc
by Shanghai MicroPort Medical (Group) Co., Ltd. China EUDAMED
Ref PH4010
EMDN C010401020102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69399638Z0257WF | Date13 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- G70 115436 0006 Issued
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 8 Oct 2026
- Expires
- 7 Oct 2031
Specification
- Device Name
- FOXTROT NC PTCA Balloon Catheter
- Model / Reference
- PH4010
- Primary DI / UDI-DI
- 06939963828502
- Basic UDI-DI
- 69399638Z0257WF
- EMDN Code
- C010401020102 Coronary stent implantation dilation catheters
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000001110
- Authorised representative
- MicroPort Medical B.V. NL-AR-000000166
Other devices from Shanghai MicroPort Medical (Group) Co., Ltd.
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Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06939963828502|69399638Z0257WF