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Cook Intrauterine Access Balloon Catheter - HSA Registration DE0509589

Access comprehensive regulatory information for Cook Intrauterine Access Balloon Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509589 and owned by Cook Incorporated. The device was registered on July 26, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0509589
Cook Intrauterine Access Balloon Catheter
HSA Registration Number: DE0509589
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Product 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0509589
Registration Date
July 26, 2024
Retention Due Date
July 25, 2025
Product Owner
Short Name
Cook Incorporated
Address
750 Daniels Way, Bloomington Indiana 47404, USA, UNITED STATES
Registrant
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Importer
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Model Information
Model Name(s)
Intrauterine Access Balloon Catheter
Model Identifier(s)
J-IAB-090023