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UNIMAX UNIMAX MONOPOLAR LAPAROSCOPIC INSTRUMENTS - HSA Registration DE0506596

Access comprehensive regulatory information for UNIMAX UNIMAX MONOPOLAR LAPAROSCOPIC INSTRUMENTS in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506596 and owned by UNIMAX MEDICAL SYSTEMS INC.. The device was registered on January 25, 2022.

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
DE0506596
UNIMAX UNIMAX MONOPOLAR LAPAROSCOPIC INSTRUMENTS
HSA Registration Number: DE0506596
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Product Description

Unimax Monopolar Laparoscopic Instruments are intended for use in general minimally invasive surgical procedures requiring the use of monopolar electrosurgical cutting and/or coagulation by use of high frequency current. The devices have applications in a variety of minimally invasive surgical procedures to facilitate mechanical grasping, mechanical transection and electrosurgical cutting, and coagulation of tissue. The Monopolar Laparoscopic Instruments are indicated to be used in general minimally invasive surgical procedures such as hysterectomy, Cholecystectomy, and Appendectomy, etc. that requiring the use of monopolar electrosurgical cutting and/or coagulation..

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0506596
Registration Date
January 25, 2022
Change Notification Approval Date
September 19, 2023
Retention Due Date
January 24, 2026
Product Owner
Short Name
UNIMAX MEDICAL SYSTEMS INC.
Address
8F, NO. 127, LN.235, BAOQIAO RD, XINDIAN DIST., NEW TAIPEI CITY, TAIWAN
Registrant
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, SINGAPORE 569880
Importer
Address
7030 Ang Mo Kio Avenue 5, SINGAPORE 569880
Model Information
Model Name(s)
Babcock Grasping Forceps Clinch Grasping Forceps Maryland Dissecting Forceps Straight Grasping Forceps Fenestrated Grasping Forceps Fenestrated Grasping Forceps Unimax Monopolar Scissors Unimax Monopolar Scissors Unimax Monopolar Scissors Unimax Monopolar Scissors Unimax Monopolar Scissors Monopolar L Hook Probe Monopolar L Hook Probe with orange handle Monopolar L Hook Probe with orange handle and cable Rat Tooth Grasping Forceps
Model Identifier(s)
FEB533050 FEC533050 FED533050 FEG533050 FEJ533050 FEJ533051 FMS533030 FMS533050 FMS533054 FMS545050 FMS545054 FPL133030 FPL533050 FPL533052 FRT533050