Taiwan FDA registration 1ac1b7e7f74f7728af3032f740213c2d

"Dragon Emperor" Coronas peripheral balloon catheter

TW: “龍帝士” 科羅娜斯周邊球囊導管

Taiwan·Risk Class 2·Rontis Corporation S.A.;; Rontis Hellas S.A.·Registered May 15, 2024 – May 15, 2029Active

Registration details

Analysis ID: 1ac1b7e7f74f7728af3032f740213c2d
Customs Code: DHA05603698901

Company information

Manufacturer: Rontis Corporation S.A.;; Rontis Hellas S.A.
Manufacturer Country: Greece;;Switzerland
Authorized Representative: SUNNY HEART SCIENTIFIC CO., LTD.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): E Cardiovascular Medicine Science
Product Type (Level 2): E.1250 Percutaneous catheters
Import Information: import

Dates and status

Registration Date: May 15, 2024
Expiry Date: May 15, 2029

About this record

Access comprehensive regulatory information for "Dragon Emperor" Coronas peripheral balloon catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1ac1b7e7f74f7728af3032f740213c2d and manufactured by Rontis Corporation S.A.;; Rontis Hellas S.A.. The authorized representative in Taiwan is SUNNY HEART SCIENTIFIC CO., LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.