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CooperSurgical RUMI II Koh-Efficient System - HSA Registration DE0012646

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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CLASS B
DE0012646
CooperSurgical RUMI II Koh-Efficient System
HSA Registration Number: DE0012646
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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.

Device 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 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