Smith & Nephew ACTICOAT FLEX 3 Silver Dressing - HSA Registration DE0008949

Access comprehensive regulatory information for Smith & Nephew ACTICOAT FLEX 3 Silver Dressing in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0008949 and owned by Smith & Nephew Medical Ltd. The device was registered on March 22, 2012.

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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HSA Official Data

CLASS C

DE0008949

Smith & Nephew ACTICOAT FLEX 3 Silver Dressing

HSA Registration Number: DE0008949

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Product Description

ACTICOAT FLEX 3 silver dressing is indicated as an antimicrobial barrier dressing over partial and full thickness wounds such as burns, recipient graft sites, surgical sites, pressure ulcers, venous ulcers and diabetic ulcers.

Device Classification

Device Class

CLASS C

Medical Speciality Area

General & Plastic Surgery

Registration Information

Registration Number

DE0008949

Registration Date

March 22, 2012

Change Notification Approval Date

January 19, 2021

Retention Due Date

March 21, 2026

Product Owner

Name

Smith & Nephew Medical Ltd

Short Name

Smith & Nephew Medical Ltd

Address

P.O. Box 81, 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)

ACTICOAT® Flex 3, 5cm x 5cm x 5's ACTICOAT® Flex 3, 10cm x 10cmx 5's ACTICOAT® Flex 3, 10cm x 10cm x 12's ACTICOAT® Flex 3, 10cm x 20cm x 12's ACTICOAT® Flex 3, 20cm x 40cm x 6's ACTICOAT® Flex 3, 40cm x 40cm x 6's ACTICOAT® Flex 3, 10cm x 120cm x 6's

Model Identifier(s)

66800396 66800398 66800399 66800409 66800419 66800432 66800435