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JJSV Laminar® Flow Phaco Tips, Flared - HSA Registration DE0003113

Access comprehensive regulatory information for JJSV Laminar® Flow Phaco Tips, Flared in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0003113 and owned by Johnson & Johnson Surgical Vision, Inc.. The device was registered on February 07, 2006.

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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CLASS B
DE0003113
JJSV Laminar® Flow Phaco Tips, Flared
HSA Registration Number: DE0003113
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Product Description

The tips are utilized in conjunction with the SOVEREIGN®, SERIES III™, SERIES 4™ and PROFINESSE II® Phaco Handpieces during the phacoemulsification procedure to break up the nucleus of the cataractous lens and remove the remaining nuclear fragments. The handpieces have been designed for use with the AMO families of phacoemulsification machines. The LAMINAR® Flow Phaco Tips are supplied sterile and are designed as reusable products for use up to 20 times.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0003113
Registration Date
February 07, 2006
Change Notification Approval Date
October 20, 2023
Retention Due Date
December 31, 2025
Product Owner
Short Name
Johnson & Johnson Surgical Vision, Inc.
Address
31 Technology Drive, Suite 200, Irvine, CA 92618, UNITED STATES
Registrant
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model Information
Model Name(s)
Tip 0° Tip 30°
Model Identifier(s)
OPOF0019L OPOF3019L