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Singapore HSA registration DE0508219

Smith & Nephew Opsite Post-Op

Singapore flagSingapore·CLASS B·Smith & Nephew Medical Limited·Registered June 20, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0508219
Registration Date
June 20, 2023
Change Notification Approval Date
July 09, 2024
Retention Due Date
June 19, 2025
Product description
OPSITE Post-Op is intended to be used by consumers for the following indications: • Cuts • Grazes • Over stitches OPSITE Post-Op is intended to be used by healthcare professionals for the following indications: • Lacerations, cuts, abrasions • Post-operative wounds • Minor burns where levels of exudate are low/moderate.
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
MLS LOGISTIC SERVICES PTE. LTD. SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED SMITH & NEPHEW PTE. LIMITED
Address
5 TAI SENG DRIVE, SCA CREATIVE CENTRE, #02-01, SINGAPORE 535217 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model information
Model Name(s)
OPSITE POST-OP 6.5cm x 5cm pk5 OPSITE POST-OP 9.5cm x 8.5cm pk3 OPSITE POST OP 6.5 X 5CM OPSITE POST OP 9.5 X 8.5CM OPSITE POST OP 15.5 X 8.5CM OPSITE POST OP 20 X 10CM OPSITE POST OP 25 X 10CM OPSITE POST OP 10 X 30CM OPSITE POST OP 10 X 35CM OPSITE POST OP BULK 6.5 X 5CM OPSITE POST OP BULK 9.5 X 8.5CM OPSITE POST-OP 6.5cm x 5cm (5 sterile dressings) OPSITE POST-OP 9.5cm x 8.5cm (3 sterile dressings)
Model Identifier(s)
36361360 36361361 66000708 66000709 66000712 66000713 66000714 66000715 66000716 66001381 66001382 97100016 97100037
About this record

Access comprehensive regulatory information for Smith & Nephew Opsite Post-Op in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508219 and owned by Smith & Nephew Medical Limited. The device was registered on June 20, 2023.

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 B