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HSA · registration DE0509589

Cook Intrauterine Access Balloon Catheter

SingaporeObstetrics & GynaecologyClass BCook Incorporated
Verified
Official record identity
Registration number
DE0509589
Model name
Intrauterine Access Balloon Catheter
Model identifier
J-IAB-090023
Registration date
July 26, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Obstetrics & Gynaecology
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Published parties
Product owner
Cook Incorporated
Registrant / registration holder
COOK SOUTH EAST ASIA PTE LTD
Official description

The Intrauterine Balloon Catheter is used for the delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6.0 French in dimeter to access the uterine cavity for assessment of tubal patency.

Additional source fields
Product owner address
750 Daniels Way, Bloomington Indiana 47404, USA, United States
Registrant address
38 BEACH ROAD, #29-11, SOUTH BEACH TOWER, Singapore 189767
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.