Identity
- Trade Name
- ZENFluxion EUDAMED
- Device Name
- Drug-coated PTA Balloon Catheter EUDAMED
- Model / Reference
- ZY075070004018A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971971818809 EUDAMED
- Basic UDI-DI
- B-06971971818809 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
Category: Peripheral angioplasty balloon catheter, basic
ZENFluxion by Zylox-Tonbridge Medical Technology Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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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-06971971818809 | Class III | Active |
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Manufacturer
- Manufacturer
- Zylox-Tonbridge Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010626
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 0c12ba78-b54b-4b41-b835-f5e2c7a3dbf7 61 fields · synced Jun 19, 2026