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CooperSurgical KOH Colpotomizer™ System - HSA Registration DE0008754

Access comprehensive regulatory information for CooperSurgical KOH Colpotomizer™ System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0008754 and owned by CooperSurgical Inc.. The device was registered on March 07, 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.

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CLASS B
DE0008754
CooperSurgical KOH Colpotomizer™ System
HSA Registration Number: DE0008754
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Product Description

The KOH Colpotomizer™ System is indicated for use in laparoscopic procedures where use of a uterine manipulator is appropriate and the surgeon intends to remove or access intraperitoneal tissue through the vagina by use of a colpotomy or culdotomy incision.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
HSA Product Code
HSAMDB00110
HS Code
90189090
Registration Information
Registration Number
DE0008754
Registration Date
March 07, 2012
Change Notification Approval Date
September 23, 2024
Retention Due Date
March 06, 2026
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)
Colpo-Pneumo Occluder ULTEM® KOH CUP™ Non-Conductive Vaginal Fornices Delineator 3.0cm ULTEM® KOH CUP™ Non-Conductive Vaginal Fornices Delineator 3.5cm ULTEM® KOH CUP™ Non-Conductive Vaginal Fornices Delineator 4.0cm ULTEM® KOH CUP™ Non-Conductive Vaginal Fornices Delineator kit KOH CUP™ 3.0cm Stainless Steel Vaginal Fornices Delineator KOH CUP™ 3.5cm Stainless Steel Vaginal Fornices Delineator KOH CUP™ 4.0cm Stainless Steel Vaginal Fornices Delineator KOH CUP™ Stainless Steel Vaginal Fornices Delineator kit
Model Identifier(s)
CPO-6 KCP-30-2 KCP-35-2 KCP-40-2 KCP-KIT KCS-30 KCS-35 KCS-40 KCS-KIT