FoxtrotTM Pro
by Shanghai MicroPort Medical (Group) Co., Ltd. 24 variants
Ref PI12010
Active
CE MDR CE MDD
Valid until
7 Oct 2031
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 115436 0006 | Date8 Oct 2026 | StatusActive |
| European Union | CE/MDD | NumberB-06939963815236 | Date2 Jun 2023 | StatusActive |
Certificates
- G70 115436 0006 Active
Technical documentation EU MDR
- Certifier
- TÜV SÜD Product Service GmbH 0123
- Issued
- 8 Oct 2026
- Expires
- 7 Oct 2031
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Trade Name
- FoxtrotTM ProFoxtrot Pro
- Device Name
- Foxtrot PRO PTCA Balloon CathetersFOXTROT PRO PTCA Balloon Catheter
- Model / Reference
- PI12010
- Primary DI / UDI-DI
- 06939963815236, 06939963804100
- Basic UDI-DI
- B-06939963815236, 69399638Z0256WD
- EMDN Code
- C010401020101 Ptca balloon dilation catheters
- Device Class
- Class III
- EU market of registration
- SpainItaly
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.
See all devices from Shanghai MicroPort Medical (Group) Co., Ltd. →
Properties
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