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Singapore HSA registration DE0507465

Medos International HEALIX ADVANCE PEEK Anchor with DYNATAPE Sutures

Singapore flagSingapore·CLASS C·Medos International SARL·Registered November 10, 2022
Device classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0507465
Registration Date
November 10, 2022
Change Notification Approval Date
March 19, 2025
Retention Due Date
November 09, 2025
Product description
The HEALIX ADVANCE PEEK Anchor with DYNATAPE Suture is intended for soft tissue to bone attachment. The HEALIX ADVANCE PEEK Anchor with DYNATAPE Suture is indicated for: Shoulder: Rotator Cuff repair.
Product Owner
Name
Medos International SARL
Short Name
Medos International SARL
Address
Chemin-Blanc 38, 2400, Le Locle, SWITZERLAND
Registrant
Name
Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Name
JOHNSON & JOHNSON PTE LTD Johnson & Johnson International (Singapore) Pte Ltd
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model information
Model Name(s)
HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture (4.5mm, White, PEEK) HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture (5.5mm, White, PEEK) HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture (6.5mm, White, PEEK) HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture (4.5mm, Black, PEEK) HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture (5.5mm, Black, PEEK) HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture (6.5mm, Black, PEEK)
Model Identifier(s)
280717 280718 280719 280729 280730 280731
About this record

Access comprehensive regulatory information for Medos International HEALIX ADVANCE PEEK Anchor with DYNATAPE Sutures in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507465 and owned by Medos International SARL. The device was registered on November 10, 2022.

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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