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Singapore HSA registration DE0016306

Integra Biopatch Protective Disk with CHG

Singapore flagSingapore·CLASS B·Integra LifeSciences Corporation·Registered September 10, 2014
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0016306
Registration Date
September 10, 2014
Change Notification Approval Date
March 12, 2024
Retention Due Date
September 09, 2025
Product description
BIOPATCH® containing Chlorhexidine Gluconate is intended for use as a hydrophilic wound dressing that is used to absorb exudate and to cover a wound caused by the use of vascular and non-vascular percutaneous medical devices such as: IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheters, drains, chest tubes, externally placed orthopedic pins, and epidural catheters. It is also intended to reduce local infections, catheter-related blood stream infections (CRBSI), and skin colonization of microorganisms commonly related to CRBSI, in patients with central venous or arterial catheters.
Product Owner
Name
Integra LifeSciences Corporation
Short Name
Integra LifeSciences Corporation
Address
1100 Campus Road, Princeton, NJ 08540, UNITED STATES
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
JOHNSON & JOHNSON PTE LTD Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
BIOPATCH Protective Disk with CHG BIOPATCH Protective Disk with CHG BIOPATCH Protective Disk with CHG
Model Identifier(s)
44150 44151 44152
About this record

Access comprehensive regulatory information for Integra Biopatch Protective Disk with CHG in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016306 and owned by Integra LifeSciences Corporation. The device was registered on September 10, 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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