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Smith & Nephew OpSite Wound dressing - HSA Registration DE0000105

Access comprehensive regulatory information for Smith & Nephew OpSite Wound dressing in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0000105 and owned by Smith & Nephew Medical Ltd. The device was registered on October 01, 2004.

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 B
DE0000105
Smith & Nephew OpSite Wound dressing
HSA Registration Number: DE0000105
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Product Description

OPSITE is indicated for: • Use as an incision drape in surgical procedures • Superficial wounds (e.g. minor burns, scalds, abrasions, and lacerations) • Split-thickness skin graft donor sites • Closed surgical wounds • Fixation of devices to the skin (i.e. catheters, tubing, primary dressings)

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0000105
Registration Date
October 01, 2004
Change Notification Approval Date
July 24, 2023
Retention Due Date
December 30, 2025
Product Owner
Short Name
Smith & Nephew Medical Ltd
Address
P.O. Box 81, 101 Hessle Road, Hull, HU3 2BN, UNITED KINGDOM
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
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)
OPSITE 11' x 4' 6 x 10's OPSITE 5 - 1/2" x 4" 6 x 10's OPSITE 5 - 1/2" x 10" 6 x 20's OPSITE Incise Drape 10cm x 14cm OPSITE Incise Drape 28cm x 15cm OPSITE Incise Drape 28cm x 30cm OPSITE Incise Drape 28cm x 45cm OPSITE Incise Drape 55cm x 45cm OPSITE Incise Drape 56cm x 84cm OPSITE Incise Drape 42cm x 40cm
Model Identifier(s)
4542 4963 4967 4975 4986 4987 4988 4989 4994 4995