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Singapore HSA registration DE0510282

Smith & Nephew HEALICOIL REGENESORB Suture Anchors with MINITAPE

Singapore flagSingapore·CLASS C·Smith & Nephew Inc. Endoscopy·Registered January 24, 2025
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0510282
Registration Date
January 24, 2025
Retention Due Date
January 23, 2026
Product description
HEALICOIL REGENESORB Suture Anchors with MINITAPE are indicated for use only for the reattachment of soft tissue to bone for the following indications: Shoulder • Rotator cuff tear repairs • Capsular shift or capsulolabral reconstructions • Biceps tenodesis
Product Owner
Name
Smith & Nephew Inc. Endoscopy
Short Name
Smith & Nephew Inc. Endoscopy
Address
150 Minuteman Road, Andover, Massachusetts, 01810, UNITED STATES
Registrant
Name
SMITH & NEPHEW PTE. LIMITED
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Name
SMITH & NEPHEW ASIA PACIFIC PTE. LIMITED SMITH & NEPHEW PTE. LIMITED
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model information
Model Name(s)
HEALICOIL REGENESORB 4.75MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) HEALICOIL REGENESORB 4.75MM SUTURE ANCHOR WITH THREE MINITAPE SUTURES (BLUE, COBRAID WHITE, COBRAID BLUE) HEALICOIL REGENESORB 5.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) HEALICOIL REGENESORB 5.5MM SUTURE ANCHOR WITH THREE MINITAP SUTURES (BLUE, COBRAID WHITE, & COBRAID BLUE)
Model Identifier(s)
72205385 72205386 72205387 72205388
About this record

Access comprehensive regulatory information for Smith & Nephew HEALICOIL REGENESORB Suture Anchors with MINITAPE in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510282 and owned by Smith & Nephew Inc. Endoscopy. The device was registered on January 24, 2025.

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 C