Singapore HSA registration DE0000105
Smith & Nephew OpSite Wound dressing
Singapore·CLASS B·Smith & Nephew Medical Ltd·Registered October 01, 2004Device 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 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)
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
About this record
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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