Singapore HSA registration DE0501725

Smith & Nephew ALLEVYN™ Gentle Border

Singapore·CLASS C·Smith & Nephew Medical Limited·Registered June 08, 2018

Device classification

Device Class: CLASS C
Medical Speciality Area: General Hospital

Registration information

Registration Number: DE0501725
Registration Date: June 08, 2018
Change Notification Approval Date: March 25, 2025
Retention Due Date: June 07, 2025

Product description

1. Wound management on shallow, granulating wounds, chronic and acute exudative wounds, full and partial thickness wounds including: • Pressure Ulcers • Leg Ulcers • Diabetic Foot Ulcers • Surgical wounds • First and second degree burns • Donor Sites • Skin tears • Fungating Ulcers 2. Pressure ulcer prevention on intact skin, including pressure ulcers caused by medical devices, as part of a pressure ulcer prevention protocol.

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

Model information

Model Name(s): ALLEVYN Gentle Border 7.5cm x 7.5cm / 3in. x 3in. x 10's ALLEVYN Gentle Border 10cm x 10cm / 4in. x 4in. x 10's ALLEVYN Gentle Border 12.5cm x 12.5cm / 5in. x 5in. x 10's ALLEVYN Gentle Border 17.5cm x 17.5cm / 7in. x 7in. x 10's ALLEVYN Gentle Border Heel 23cm x 23.2cm / 9in. x 9 1/8in. x 10's ALLEVYN Gentle Border Sacrum Dressing 16.8cm x 17.1cm / 6 5/8in. x 6 3/4in. x 10's ALLEVYN Gentle Border 10cm x 20cm / 4in. x 8in. x 10's ALLEVYN Gentle Border Multisite 17.1cm x 17.9cm / 6 3/4in. x 7 1/16in. x 10's ALLEVYN Gentle Border 15cm x 15cm / 6in. x 6in. x 10's ALLEVYN Gentle Border Sacrum Dressing 21.6cm x 23cm / 8 1/2in. x 9in. x 10's
Model Identifier(s): 66800269 66800270 66800272 66800273 66800506 66800898 66800900 66800959 66800975 66801031

About this record

Access comprehensive regulatory information for Smith & Nephew ALLEVYN™ Gentle Border in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501725 and owned by Smith & Nephew Medical Limited. The device was registered on June 08, 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.

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