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Coopersurgical Arch Koh-Efficient System - HSA Registration DE0012827

Access comprehensive regulatory information for Coopersurgical Arch 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 DE0012827 and owned by Coopersurgical Inc.. The device was registered on May 06, 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
DE0012827
Coopersurgical Arch Koh-Efficient System
HSA Registration Number: DE0012827
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Product Description

Advincula Arch Handle is designed for use in operative endoscopy (laparoscopy), where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries or vagina is desirable. The Koh-Efficient is a combination KOH Cupโ„ข and Colpo-Pneumo Occluderโ„ข that is indicated for use in laparoscopic procedures where it is desirable to locate the position of the vaginal fornices, typically during a total laparoscopic hysterectomy or supra-cervical laparoscopic hysterectomy. The Arch Koh-Efficientโ„ข is to be used with the Advincula Arch Handle.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
HSA Product Code
HSAMDB00110
HS Code
90189090
Registration Information
Registration Number
DE0012827
Registration Date
May 06, 2013
Change Notification Approval Date
September 23, 2024
Retention Due Date
May 05, 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)
Plastic Arch Koh-Efficient Plastic Arch Koh-Efficient Plastic Arch Koh-Efficient Plastic Arch Koh-Efficient Steel Arch Koh-Efficient Steel Arch Koh-Efficient Steel Arch Koh-Efficient Steel Arch Koh-Efficient Advincula Arch Handle
Model Identifier(s)
KC-ARCH-25 KC-ARCH-30 KC-ARCH-35 KC-ARCH-40 KCS-ARCH-25 KCS-ARCH-30 KCS-ARCH-35 KCS-ARCH-40 UMH750