HSA · registration DE0508345KCI PREVENA RESTOR™ INCISION MANAGEMENT SYSTEM
SingaporeGeneral & Plastic SurgeryClass BKCI USA, Inc.
Official record identity
- Registration number
- DE0508345
- Model name
- PREVENA PLUS™ 125 THERAPY UNIT (Software Version 3.01) WITH PREVENA PLUS™150ML CANISTER; PREVENA PLUS™ 150mL Canister; 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
- PRE4010; PRE4095; PRE5221; PRE5255; PRE5321; PRE5355; PRE5421; PRE5455
- Registration date
- July 31, 2023
- Source update date
- August 11, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- KCI USA, Inc.
- Registrant / registration holder
- KCI MEDICAL ASIA PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- 12930 IH 10 West, San Antonio, Texas, 78249, United States
- Registrant address
- 10 ANG MO KIO STREET 65, #01-01, TECHPOINT, Singapore 569059
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.