Singapore HSA registration DE0012646
CooperSurgical RUMI II Koh-Efficient System
Singapore·CLASS B·Coopersurgical Inc.·Registered March 27, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Obstetrics & Gynaecology
- HSA Product Code
- HSAMDB00110
- HS Code
- 90189090
Registration information
- Registration Number
- DE0012646
- Registration Date
- March 27, 2013
- Change Notification Approval Date
- September 23, 2024
- Retention Due Date
- March 26, 2026
Product description
The Koh-Efficient is a combination KOH Cup and Colpo-Pneumo Occluder that is indicated for use in laparoscopic procedures where it is desirable to locate the position of the vaginal fornicles, typically during a total laparoscopic hysterectomy or supra-cervical laparoscopic hysterectomy. The RUMI II Koh-Efficient is to be used only with the RUMI II handle.
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)
- RUMI® / Koh-Efficient™ 2.5 cm RUMI® / Koh-Efficient™ 3.0 cm RUMI® / Koh-Efficient™ 3.5 cm RUMI® / Koh-Efficient™ 4.0 cm Cervical Sizer Stainless Steel Capped RUMI® II / Koh-Efficient 2.5cm Stainless Steel Capped RUMI® II / Koh-Efficient 3.0cm Stainless Steel Capped RUMI® II / Koh-Efficient 3.5cm Stainless Steel Capped RUMI® II / Koh-Efficient 4.0cm Disposable Uterine Manipulator Tip Disposable Uterine Manipulator Tip RUMI II HANDLE Disposable Uterine Manipulator Tip Disposable Uterine Manipulator Tip Disposable Uterine Manipulator Tip
- Model Identifier(s)
- KC-RUMI-25 KC-RUMI-30 KC-RUMI-35 KC-RUMI-40 KC-SIZER KCS-RUMI-25 KCS-RUMI-30 KCS-RUMI-35 KCS-RUMI-40 UMB678 UMG670 UMH650 UML516 UMO672 UMW676
About this record
Access comprehensive regulatory information for CooperSurgical RUMI II Koh-Efficient 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 DE0012646 and owned by Coopersurgical Inc.. The device was registered on March 27, 2013.
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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