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EUDAMED registration 06935456205881No

Sterile Single Use Peripheral Arteries Percutaneous Transluminal Angioplasty(PTA) Dilatation Catheter

Princeton Medical Scientific Co.,LtdClass IIaEU EUDAMEDTrade name: Principal® Peripheral Arteries Percutaneous Transluminal Angioplasty(PTA) Dilatation Catheter
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
C010402020101
Trade name
Principal® Peripheral Arteries Percutaneous Transluminal Angioplasty(PTA) Dilatation Catheter
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
06935456205881
Basic UDI
69354562PLYL06XM
Active status
No
Manufacturer
Manufacturer name
Princeton Medical Scientific Co.,Ltd
Country
China
Country type
NON_EU
Address
No.8 Fukang West Street, Yushu Industrial Park, Guangzhou city, Guangdong Province
Email
pssu@pulinmed.com
Authorized representative
Name
Wellkang Ltd
SRN
XI-AR-000001836
Country
United Kingdom (Northern Ireland only)
Address
Enterprise Hub, NW Business Complex, Derry
Email
AuthRep@CE-marking.eu
Telephone
+44(33)33031126
Regulatory information
Competent authority
The Medicines and Healthcare Products Regulatory Agency
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Türkiye
Market available
Türkiye:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

PTA BALLOON DILATATION CATHETERS

About this record

Access comprehensive regulatory information for Sterile Single Use Peripheral Arteries Percutaneous Transluminal Angioplasty(PTA) Dilatation Catheter in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06935456205881 and manufactured by Princeton Medical Scientific Co.,Ltd in China.

This page provides complete registration details including trade name (Principal® Peripheral Arteries Percutaneous Transluminal Angioplasty(PTA) Dilatation Catheter ), manufacturer information, authorized representative details, competent authority (The Medicines and Healthcare Products Regulatory Agency), 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.