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Drug-coated PTA Balloon Catheter - EUDAMED Registration 06974042971373

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 06974042971373 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.

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EUDAMED Official Data
Class III
06974042971373
No
Drug-coated PTA Balloon Catheter
Trade Name: ZENFluxion
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Device Description (EMDN)

PTA BALLOON DILATATION CATHETERS

Device Classification
Risk Class
Class III
CND Nomenclatures Code
C010402020101
Trade Name
ZENFluxion
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06974042971373
Basic UDI
B-06974042971373
Version Date
April 28, 2022
Manufacturer Last Update
October 13, 2021
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
18 Floor 1&2, Buliding No.1, 18 Keji Avenue, Yuhang Street, Yuhang District Hangzhou, Zhejiang Province
Email
ra@zyloxmedical.com
Authorized Representative
SRN
DE-AR-000000001
Country
Germany
Address
80 EiffestraรŸe Hamburg
Email
shholding@hotmail.com
Telephone
+49 40 2513175
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No