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Singapore HSA registration DE0010798

CooperSurgical Zumi 4.5 Uterine Manipulator-Injector

Singapore flagSingapore·CLASS B·CooperSurgical Inc.·Registered September 12, 2012
Device classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
HSA Product Code
HSAMDB00110
HS Code
90189090
Registration information
Registration Number
DE0010798
Registration Date
September 12, 2012
Change Notification Approval Date
September 23, 2024
Retention Due Date
September 11, 2025
Product description
The ZUMI 4.5 is indicated in diagnostic laparoscopy, minilaparotomy, fertility examinations and salpingoplastic procedures where manipulation of the uterus is required. This product also facilitates the sealing of the cervical OS while providing a fluid or air injection port.
Product Owner
Name
CooperSurgical Inc.
Short Name
CooperSurgical Inc.
Address
95 Corporate Drive, Trumbull Connecticut, 06611, UNITED STATES
Registrant
Name
COOPERSURGICAL ORIGIO PTE LTD
Address
1 TEMASEK AVENUE, MILLENIA TOWER, #39-01, SINGAPORE 039192
Importer
Name
HEALTHCARE ESSENTIALS PTE LTD IDS MEDICAL SYSTEMS (SINGAPORE) PTE LTD
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)
Zumi 4.5 Uterine Manipulator-Injector
Model Identifier(s)
ZSI1151
About this record

Access comprehensive regulatory information for CooperSurgical Zumi 4.5 Uterine Manipulator-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 DE0010798 and owned by CooperSurgical Inc.. The device was registered on September 12, 2012.

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