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Singapore HSA registration DE0019367

Smith & Nephew BIOBRANE Temporary Wound Dressing

Singapore flagSingapore·CLASS D·Smith & Nephew Medical Limited·Registered June 29, 2017
Device classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0019367
Registration Date
June 29, 2017
Change Notification Approval Date
March 20, 2024
Retention Due Date
June 28, 2025
Product description
BIOBRANE is intended for covering clean partial thickness wounds and split thickness donor sites. BIOBRANE Gloves are indicated for covering clean partial thickness burn wounds of the hand.
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)
BIOBRANE 13cm X 13cm (Single) BIOBRANE 13cm x 38cm (Single) BIOBRANE 25cm X 38cm (Single) BIOBRANE Glove Pediatric (Single) BIOBRANE Glove Medium (Single) BIOBRANE Glove Large (Single) BIOBRANE 13cm x 13cm BIOBRANE 13cm x 38cm BIOBRANE 25cm x 38cm BIOBRANE 38cm x 50cm BIOBRANE Glove Pediatric BIOBRANE Glove Small BIOBRANE Glove Medium BIOBRANE Glove Large BIOBRANE 13cm x 13cm BIOBRANE 13cm x 38cm BIOBRANE 25cm x 38cm BIOBRANE Glove Pediatric x 1 BIOBRANE Glove Medium x 1 BIOBRANE Glove Large x 1 BIOBRANE 13cm x 13cm BIOBRANE 13cm x 38cm BIOBRANE 25cm x 38cm BIOBRANE 38cm x 50cm BIOBRANE Glove Pediatric x 2 BIOBRANE Glove Small x 2 BIOBRANE Glove Medium x 2 BIOBRANE Glove Large x 2
Model Identifier(s)
66800046 66800047 66800048 66800049 66800051 66800052 66800174 66800175 66800176 66800177 66800181 66800182 66800183 66800184 66802156 66802157 66802158 66802159 66802160 66802161 66802162 66802163 66802164 66802165 66802166 66802167 66802168 66802169
About this record

Access comprehensive regulatory information for Smith & Nephew BIOBRANE Temporary Wound Dressing in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0019367 and owned by Smith & Nephew Medical Limited. The device was registered on June 29, 2017.

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 D