Singapore HSA registration DE0509589
Cook Intrauterine Access Balloon Catheter
Singapore·CLASS B·Cook Incorporated·Registered July 26, 2024Device 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 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.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B