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Smith & Nephew ALLEVYN™ Gentle Border - HSA Registration DE0501725

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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CLASS C
DE0501725
Smith & Nephew ALLEVYN™ Gentle Border
HSA Registration Number: DE0501725
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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.

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 Owner
Short Name
Smith & Nephew Medi
Address
101 Hessle Road, Hull HU3 2BN, UNITED KINGDOM
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
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