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Singapore HSA registration DE0504475

KCI PREVENA PLUS™ Incision Management System

Singapore flagSingapore·CLASS B·KCI USA, Inc.·Registered May 13, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0504475
Registration Date
May 13, 2020
Change Notification Approval Date
June 08, 2023
Retention Due Date
May 12, 2025
Product description
The PREVENA PLUS™ Incision Management System is intended to manage the environment of closed surgical incisions and surrounding intact skin in patients at risk for developing post-operative complications, such as infection, by maintaining a closed environment via the application of a negative pressure wound therapy system to the incision. The PREVENA™ Dressing skin interface layer with silver reduces microbial colonization in the fabric.
Product Owner
Name
KCI USA, Inc.
Short Name
KCI USA, Inc.
Address
12930 Interstate 10 West, San Antonio, Texas, 78249, UNITED STATES
Registrant
Name
KCI MEDICAL ASIA PTE. LTD.
Address
10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Importer
Name
KCI MEDICAL ASIA PTE. LTD.
Address
10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Model information
Model Name(s)
PREVENA PLUS™ PEEL & PLACE™ System Kit – 35cm PREVENA™ PEEL & PLACE™ Dressing-35cm PREVENA PLUS™ Incision Management System PREVENA PLUS™ CUSTOMIZABLE™ Dressing with SENSAT.R.A.C.™ Technology PREVENA PLUS™ 150mL Canister PREVENA™ V.A.C.® Connector
Model Identifier(s)
PRE3201 PRE3255 PRE4001UK PRE4055 PRE4095 PRE9090
About this record

Access comprehensive regulatory information for KCI PREVENA PLUS™ Incision Management 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 DE0504475 and owned by KCI USA, Inc.. The device was registered on May 13, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B