Identity
- Trade Name
- ZENFlex Pro EUDAMED
- Device Name
- Peripheral Drug-eluting Stent System EUDAMED
- Model / Reference
- ZX07150080A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971971816508 EUDAMED
- Basic UDI-DI
- B-06971971816508 EUDAMED
- EMDN Code
- P0704020203 PERIPHERAL VASCULAR DRUG ELUTING STENTS (DES) EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
ZENFlex Pro by Zylox-Tonbridge Medical Technology Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971971816508 | Class III | Unknown |
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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 5979d472-a830-406d-b823-ac0c4292e0e3 61 fields · synced Jun 18, 2026