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BALLOON DILATED CATHETER ADAPTERS/CONNECTORS FOR ANGIOPLASTY - ARCSA Registration 7f5e396222d32faa0d114a0e111c892a

Access comprehensive regulatory information for BALLOON DILATED CATHETER ADAPTERS/CONNECTORS FOR ANGIOPLASTY in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID 7f5e396222d32faa0d114a0e111c892a and manufactured by KOSSEL MEDTECH (SUZHOU) CO, LTD. The device was registered on August 17, 2020.

This page provides complete registration details including product type (Invasive), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.

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ARCSA Official Data
IV
7f5e396222d32faa0d114a0e111c892a
BALLOON DILATED CATHETER ADAPTERS/CONNECTORS FOR ANGIOPLASTY
ARCSA ID: 7f5e396222d32faa0d114a0e111c892a
Local name: ADAPTADORES/CONECTORES, DE CATร‰TER CON DILATACIร“N POR BALร“N PARA ANGIOPLASTIA
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Device Classification
Risk Class
IV
Product Type
Invasive
Brand Name
CC MED - DEVICES
Commercial Name
BALLOON DILATED CATHETER ADAPTERS/CONNECTORS FOR ANGIOPLASTY
Sterilization Method
ETHYLENE OXIDE
Registration Information
Analysis ID
7f5e396222d32faa0d114a0e111c892a
Registration Date
August 17, 2020
Expiration Date
August 17, 2025
Creation Date
August 17, 2020
Product Use

THE SIROLIMUS-ELUTING CORONARY STENT IS A DEVICE/DRUG COMBINATION PRODUCT COMPOSED OF TWO REGULATED COMPONENTS: A DEVICE (A CORONARY STENT DELIVERY SYSTEM) AND A PHARMACOLOGICAL PRODUCT (A FORMULATION OF SIROLIMUS IN A POLYMER COATING). IT IS A RAPID EXCHANGE (XR) STENT SYSTEM INDICATED TO IMPROVE CORONARY LUMINAL DIAMETER AND MYOCARDIAL BLOOD FLOW.

Manufacturer
City
SUZHOU CHINA
Country
CHINA
Address
F3, BUILDING 6, NO. 8 JINFENG ROAD, SUZHOU NEW DISTRICT , CHINA
Product Owner
Name
KOSSEL MEDTECH (SUZHOU) CO, LTD
Country
CHINA
Authorized Representative
Address
MANTA / SANTA MARIANITA (BOCA DE PACOCHE) / JORGE EDUARDO ESTUPIร‘AN DIDON LOT 803 AND CAMINO DE LOS ANCIANOS
Phone
999255433