Singapore HSA registration DE0007979
CooperSurgical Zui Uterine Injector
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Obstetrics & Gynaecology
- HSA Product Code
- HSAMDB00109
- HS Code
- 90189090
Registration information
- Registration Number
- DE0007979
- Registration Date
- November 22, 2011
- Change Notification Approval Date
- September 24, 2024
- Retention Due Date
- December 31, 2025
Product description
Zinnanti Uterine Injector is indicated for in-office or hospital use when efficient sealing of the uterine cervix is required for the injection of liquid or gas such as hysterosalpingography, salpingoplasties, hydrotubation and Rubin’s Test. Can be used without cervical dilation or anesthesia if the uterus can be sounded easily with a standard uterine sound.
Product Owner
- Short Name
- CooperSurgical Inc.
- Address
- 95 Corporate Drive, Trumbull Connecticut, 06611, UNITED STATES
Registrant
- Address
- 1 TEMASEK AVENUE, MILLENIA TOWER, #39-01, SINGAPORE 039192
Importer
- Address
- 1023 YISHUN INDUSTRIAL PARK A, YISHUN INDUSTRIAL PARK A, #02-19, SINGAPORE 768762 1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model information
- Model Name(s)
- ZUI 4.0™ Uterine Injector ZUI 2.0™ Uterine Injector
- Model Identifier(s)
- ZSI1152 ZSI1153
About this record
Access comprehensive regulatory information for CooperSurgical Zui Uterine Injector in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0007979 and owned by CooperSurgical Inc.. The device was registered on November 22, 2011.
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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