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Singapore HSA registration DE0507545

Cipher OpClear Control Unit System CS-CU33

Singapore flagSingapore·CLASS B·Cipher Surgical Ltd.·Registered November 25, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0507545
Registration Date
November 25, 2022
Retention Due Date
November 24, 2025
Product description
The OpClear Platform consists of a reusable Control Unit and a range of disposable sterile single-use accessories intended to remove visual obstructions on the distal window of laparoscopes, such as condensation, blood, and other tissue particulates, therefore maintaining a clear image view of the surgical site. The OpClear Platform is indicated for use in abdominal laparoscopy.
Product Owner
Name
Cipher Surgical Ltd.
Short Name
Cipher Surgical Ltd.
Address
THE VENTURE CENTRE,, SIR WILLIAM LYONS ROAD, COVENTRY, CV4 7EZ, UNITED KINGDOM
Registrant
Name
EMMED PTE LTD
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, SINGAPORE 569880
Importer
Name
EMMED PTE LTD
Address
7030 Ang Mo Kio Avenue 5, SINGAPORE 569880
Model information
Model Name(s)
OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Sterile Single Use Procedure Kit OpClear Control Unit System
Model Identifier(s)
CS-05-00-290 CS-05-00-300 CS-05-00-315 CS-05-30-290 CS-05-30-300 CS-05-30-315 CS-10-00-300 CS-10-00-315 CS-10-00-330 CS-10-30-300 CS-10-30-315 CS-10-30-330 CS-CU33-H1P1M3
About this record

Access comprehensive regulatory information for Cipher OpClear Control Unit System CS-CU33 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507545 and owned by Cipher Surgical Ltd.. The device was registered on November 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B