Singapore HSA registration DE0501151

Smith & Nephew RENASYS Negative Pressure Wound Therapy System

Singapore·CLASS C·Smith & Nephew Medical Limited·Registered January 25, 2018

Device classification

Device Class: CLASS C
Medical Speciality Area: General Hospital

Registration information

Registration Number: DE0501151
Registration Date: January 25, 2018
Change Notification Approval Date: July 16, 2024
Retention Due Date: January 24, 2026

Product description

It is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy), as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. Appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.

Product Owner

Name: Smith & Nephew Medical Limited
Short Name: Smith & Nephew Medi
Address: 101 Hessle Road, Hull HU3 2BN, UNITED KINGDOM

Registrant

Name: SMITH & NEPHEW PTE. LIMITED
Address: 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565

Importer

Name: DCH AURIGA SINGAPORE SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED SMITH & NEPHEW PTE. LIMITED
Address: 10 RAEBURN PARK, #01-33, SINGAPORE 088702 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565

Model information

Model Name(s): Renasys Transparent Film Dressing (8in x 12in / 20cm x 30cm) Renasys-F Foam Dressing Kit with Soft Port, Small Kit (10 x 8 x 3cm / 3.9 x 3.1 x 1.2in) Renasys-F Foam Dressing Kit with Soft Port, Medium Kit (20 x 12.5 x 3cm / 7.9 x 4.9 x 1.2in) Renasys-F Foam Dressing Kit with Soft Port, Large Kit (25 x 15 x 3cm / 9.8 x 5.9 x 1.2in) Renasys-F Foam Dressing Kit with Soft Port, X-Large Kit (48 x 41 x 1.5cm / 18.9 x 16.1 x 0.6in) Renasys Soft Port, Stand-alone Renasys Transparent Film Dressing (15in x 24in / 38cm x 60cm) Renasys-G Gauze Dressing Kit with Soft Port, Small Kit Renasys-G Gauze Dressing Kit with Soft Port, Medium Kit Renasys-G Gauze Dressing Kit with Soft Port, Large Kit Renasys-G Gauze Dressing Kit with Soft Port, Extra Large Kit Renasys-G Sterile Gauze Dressing Kit with Soft Port Renasys AB Abdominal Dressing Kit with Soft Port Foam Wound Dressing Renasys Adhesive Gel Patch Renasys-G 10Fr Round Drain Gauze Dressing Kit Renasys-G 10mm Flat Drain Gauze Dressing Kit Renasys-G 15Fr Channel Drain Gauze Dressing Kit Renasys-G 19Fr Round Drain Gauze Dressing Kit RENASYS EZ MAX Negative Pressure Wound Therapy (Professional Healthcare Facility Model) RENASYS EZ MAX Negative Pressure Wound Therapy RENASYS GO Negative Pressure Wound Therapy White Foam Negative Pressure Wound Therapy Wound Dressing 7.5cm x 10cm x 0.9 cm, 10's White Foam Negative Pressure Wound Therapy Wound Dressing 10cm x 15cm x 0.9 cm, 10's Gauze Wound Dressing
Model Identifier(s): 66800394 66800794 66800795 66800796 66800797 66800799 66800853 66800933 66800934 66800935 66800936 66800961 66800980 66801021 66801082 66801255 66801256 66801257 66801258 66801309 66801310 66801496 66801787 66801788 66802127

About this record

Access comprehensive regulatory information for Smith & Nephew RENASYS Negative Pressure Wound Therapy System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501151 and owned by Smith & Nephew Medical Limited. The device was registered on January 25, 2018.

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 C