Identity
- Trade Name
- FoxtrotTM NC EUDAMED
- Device Name
- Foxtrot NC PTCA Balloon Catheters EUDAMED
- Model / Reference
- PH3520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939963816240 EUDAMED
- Basic UDI-DI
- B-06939963816240 EUDAMED
- EMDN Code
- C010401020101,C010401020102 EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
FoxtrotTM NC by Shanghai MicroPort Medical (Group) Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06939963816240 | Class III | Active |
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Manufacturer
- Manufacturer
- Shanghai MicroPort Medical (Group) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001110
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED e24e7307-40ae-4f7c-8215-4c9f6120d9a5 61 fields · synced Jun 18, 2026