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CooperSurgical Advincula Delineator Uterine Manipulator with Ultem Koh-Efficient Technology - HSA Registration DE0504351

Access comprehensive regulatory information for CooperSurgical Advincula Delineator Uterine Manipulator with Ultem Koh-Efficient Technology in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504351 and owned by CooperSurgical Inc.. The device was registered on April 08, 2020.

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
DE0504351
CooperSurgical Advincula Delineator Uterine Manipulator with Ultem Koh-Efficient Technology
HSA Registration Number: DE0504351
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Product Description

The CooperSurgical Advincula Delineator Uterine Manipulator is indicated to provide delineation of the vaginal fornices and maintain pneumoperitoneum as a uterine manipulator during Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH) and/or Laparoscopic Supracervical Hysterectomy (LSH).

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504351
Registration Date
April 08, 2020
Change Notification Approval Date
September 23, 2024
Retention Due Date
April 07, 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)
Advincula Delineator Uterine Manipulator with 2.5 cm Ultem Koh Efficient Advincula Delineator Uterine Manipulator with 3.0 cm Ultem Koh Efficient Advincula Delineator Uterine Manipulator with 3.5 cm Ultem Koh Efficient Advincula Delineator Uterine Manipulator with 4.0 cm Ultem Koh Efficient
Model Identifier(s)
AD750-KE25 AD750-KE30 AD750-KE35 AD750-KE40