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JJSV Laminarยฎ Flow Phaco Tips - HSA Registration DE0003082

Access comprehensive regulatory information for JJSV Laminarยฎ Flow Phaco Tips in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0003082 and owned by Johnson & Johnson Surgical Vision, Inc.. The device was registered on February 06, 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
DE0003082
JJSV Laminarยฎ Flow Phaco Tips
HSA Registration Number: DE0003082
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Product Description

The phaco tips are used to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments. The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery. The Phacoemulsification tip is intended for use in conjunction with the Irrigation Sleeve during ocular surgery.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0003082
Registration Date
February 06, 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 19 Gauge 15ยฐ Tip 19 Gauge 30ยฐ
Model Identifier(s)
OPOR1519L OPOR3019L