Singapore HSA registration DE0008754
CooperSurgical KOH Colpotomizer™ System
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 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.
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
About this record
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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