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Singapore HSA registration DE0510483

Smith & Nephew HEALICOIL PK Suture Anchors with MINITAPE

Singapore flagSingapore·CLASS C·Smith & Nephew Inc. Endoscopy·Registered March 20, 2025
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0510483
Registration Date
March 20, 2025
Retention Due Date
March 19, 2026
Product description
Smith & Nephew HEALICOIL PK Suture Anchors with MINITAPE are intended for use only for the reattachment of soft tissue to bone for the following indications: Shoulder • Rotator cuff tear repair • Biceps tenodesis Hip • Gluteal tendon repair • Gluteus minimus/medius repair
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 PK 4.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) HEALICOIL PK 5.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) HEALICOIL PK 5.5MM SUTURE ANCHOR WITH THREE MINITAPE SUTURES (BLUE, COBRAID WHITE, COBRAID BLUE)
Model Identifier(s)
72205381 72205382 72205383
About this record

Access comprehensive regulatory information for Smith & Nephew HEALICOIL PK 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 DE0510483 and owned by Smith & Nephew Inc. Endoscopy. The device was registered on March 20, 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