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Singapore HSA registration DE0508345

KCI PREVENA RESTOR™ INCISION MANAGEMENT SYSTEM

Singapore flagSingapore·CLASS B·KCI USA, Inc.·Registered July 31, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0508345
Registration Date
July 31, 2023
Change Notification Approval Date
October 21, 2024
Retention Due Date
July 30, 2025
Product description
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.
Product Owner
Name
KCI USA, Inc.
Short Name
KCI USA, Inc.
Address
12930 IH 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
3M TECHNOLOGIES (S) PTE. LTD. KCI MEDICAL ASIA PTE. LTD.
Address
10 ANG MO KIO STREET 65, TECHPOINT, #03-01, SINGAPORE 569059 10 ANG MO KIO STREET 65, TECHPOINT, #01-01, SINGAPORE 569059
Model information
Model Name(s)
PREVENA PLUS™ 125 THERAPY UNIT (Software Version 3.01) WITH PREVENA PLUS™150ML CANISTER PREVENA PLUS™ 150mL Canister PREVENA RESTOR ARTHRO•FORM™ SYSTEM - 33CM x 30CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR ARTHRO•FORM™ DRESSING- 33CM x 30CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR ARTHRO•FORM™ SYSTEM - 46CM x 30CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR ARTHRO•FORM™ DRESSING- 46CM x 30CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR BELLA•FORM™ SYSTEM - 21CM x 19CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR BELLA•FORM™ DRESSING - 21CM x 19CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR BELLA•FORM™ SYSTEM - 24CM x 22CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR BELLA•FORM™ DRESSING - 24CM x 22CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR BELLA•FORM™ SYSTEM - 29CM x 27CM WITH SENSAT.R.A.C.™ TECHNOLOGY PREVENA RESTOR BELLA•FORM™ DRESSING - 29CM x 27CM WITH SENSAT.R.A.C.™ TECHNOLOGY
Model Identifier(s)
PRE4010 PRE4095 PRE5001 PRE5055 PRE5101 PRE5155 PRE5221 PRE5255 PRE5321 PRE5355 PRE5421 PRE5455
About this record

Access comprehensive regulatory information for KCI PREVENA RESTOR™ 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 DE0508345 and owned by KCI USA, Inc.. The device was registered on July 31, 2023.

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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