Drug-coated PTA Balloon Catheter
- Risk class
- Class III
- CND nomenclatures code
- C010402020101
- Trade name
- ZENFluxion
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06974042971366
- Basic UDI
- B-06974042971366
- Version date
- April 28, 2022
- Manufacturer last update
- October 13, 2021
- Active status
- No
- Manufacturer name
- Zhejiang Zylox Medical Device Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- 18 Floor 1&2, Buliding No.1, 18 Keji Avenue, Yuhang Street, Yuhang District Hangzhou, Zhejiang Province
- ra@zyloxmedical.com
- SRN
- DE-AR-000000001
- Country
- Germany
- Address
- 80 Eiffestraße Hamburg
- shholding@hotmail.com
- Telephone
- +49 40 2513175
- Competent authority
- DE/CA05 - Behorde fur Justiz und Verbraucherschutz
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Italy
- Market available
- Bulgaria:None~None, Czech Republic:None~None, Italy:None~None
- Human tissues
- No
- Animal tissues
- No
PTA BALLOON DILATATION CATHETERS
Access comprehensive regulatory information for Drug-coated PTA Balloon Catheter in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 06974042971366 and manufactured by Zhejiang Zylox Medical Device Co., Ltd. in China.
This page provides complete registration details including trade name (ZENFluxion), manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.