Singapore HSA registration DE0003114
JJSV Phacofit® Titanium 0.3mm
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0003114
- Registration Date
- February 07, 2006
- Change Notification Approval Date
- October 20, 2023
- Retention Due Date
- December 31, 2025
Product description
They are indicated for use during cataract extraction to provide irrigation and aspiration functions. They have been designed for use with the AMO families of phacoemulsification machines.
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)
- Straight Tip 45 Tip 90 Tip
- Model Identifier(s)
- OMO551011 OMO551013 OMO551014
About this record
Access comprehensive regulatory information for JJSV Phacofit® Titanium 0.3mm in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0003114 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B