Singapore HSA registration DE0003082
JJSV Laminar® Flow Phaco Tips
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 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.
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 15° Tip 19 Gauge 30°
- Model Identifier(s)
- OPOR1519L OPOR3019L
About this record
Access comprehensive regulatory information for JJSV Laminar® 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B