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HIGH PRESSURE BALLOON DILATATION CATHETER - ARCSA Registration fcb534c5f3582912fbe971dd851e2818

Access comprehensive regulatory information for HIGH PRESSURE BALLOON DILATATION CATHETER in the Ecuador medical device market through Pure Global AI's free database. This IV medical device is registered under ARCSA ID fcb534c5f3582912fbe971dd851e2818 and manufactured by KOSSEL MEDTECH (SUZHOU) CO, LTD. The device was registered on August 24, 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
fcb534c5f3582912fbe971dd851e2818
HIGH PRESSURE BALLOON DILATATION CATHETER
ARCSA ID: fcb534c5f3582912fbe971dd851e2818
Local name: CATETER BALON DE DILATACION ALTA PRESION
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Device Classification
Risk Class
IV
Product Type
Invasive
Brand Name
CC MED - DEVICES
Commercial Name
CATHETERS, FOR ANGIOPLASTY, BALLOON DILATION, CORONARY PARAPERFUSION
Sterilization Method
ETHYLENE OXIDE
Registration Information
Analysis ID
fcb534c5f3582912fbe971dd851e2818
Registration Date
August 24, 2020
Expiration Date
August 24, 2025
Creation Date
August 24, 2020
Product Use

RAPID EXCHANGE BALLOON (RX) CATHETER USED FOR THE PURPOSE OF DILATING THE STENOTIC PORTION OF A CORONARY ARTERY OR SHUNT GRAFT STENOSIS IN ORDER TO IMPROVE MYOCARDIAL PERFUSION.

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 ESTUPIÑAN DIDON LOT 803 AND CAMINO DE LOS ANCIANOS
Phone
999255433