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Singapore HSA registration DE0016364

KCI ABTHERA™ Open Abdomen Dressing

Singapore flagSingapore·CLASS B·KCI USA, Inc.·Registered September 30, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0016364
Registration Date
September 30, 2014
Change Notification Approval Date
February 08, 2022
Retention Due Date
September 29, 2025
Product description
The ABTHERA™ Open Abdomen Dressing is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. The Intended Use of this dressing is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.
Product Owner
Name
KCI USA, Inc.
Short Name
KCI USA, Inc.
Address
12930 IH 10 West, San Antonio, TX 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)
ABTHERA ADVANCE™ Open Abdomen Dressing ABThera™ SensaT.R.A.C.™ Open Abdomen Dressing
Model Identifier(s)
ABT1055 M8275026/5
About this record

Access comprehensive regulatory information for KCI ABTHERA™ Open Abdomen Dressing in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016364 and owned by KCI USA, Inc.. The device was registered on September 30, 2014.

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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