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Foxtrot NC PTCA Balloon Catheters
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref PH2206
Identity
- Trade Name
- Foxtrot NC PTCA Balloon Catheters EUDAMED
- Device Name
- Foxtrot NC PTCA Balloon Catheters EUDAMED
- Model / Reference
- PH2206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06939963815892 EUDAMED
- Basic UDI-DI
- B-06939963815892 EUDAMED
- EMDN Code
- C010401020101,C010401020102 EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye 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
Foxtrot NC PTCA Balloon Catheters by Shanghai MicroPort Medical (Group) Co., Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143160 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06939963815892 | 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 (2)
- EUDAMED aa66cd61-6170-471f-a102-af3d1233f89a 61 fields · synced Oct 6, 2026
- FDA 510(k) K143160 1 fields · synced May 18, 2026