ZENFlow
by Zylox-Tonbridge Medical Technology Co., Ltd. 744 variants
Ref ZW100030006035B
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
Introducing the ZenFlow device, a reliable and accurate medical device for balloon catheterization. With its legacy-based design, the ZenFlow offers improved patient outcomes and enhanced clinical decision-making. Our team of experts has carefully evaluated this device to ensure it meets the highest standards of quality and safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06970596420732 06970596420732 | Date21 Oct 2021 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- PTA Balloon Catheter
- Model / Reference
- ZW100030006035B
- Primary DI / UDI-DI
- 06970596420732
- Basic UDI-DI
- B-06970596420732
- EMDN Code
- C010402020101 PTA balloon dilatation catheters
- Device Class
- Class IIa
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000010626
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Zylox-Tonbridge Medical Technology Co., Ltd.
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Properties
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No