Identity
- Trade Name
- ZENFlex EUDAMED
- Device Name
- Peripheral Stent System EUDAMED
- Model / Reference
- ZX07100125B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970596426734 EUDAMED
- Basic UDI-DI
- B-06970596426734 EUDAMED
- EMDN Code
- P070402020102 NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ZENFlex by Zylox-Tonbridge Medical Technology Co., Ltd. — Class IIb — 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-06970596426734 | Class IIb | 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 cc65ce88-d5db-4482-9aa7-8a54eea490e1 61 fields · synced Jun 18, 2026