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Singapore HSA registration DE0508597

Bausch + Lomb Ultra One Day for Astigmatism Contact Lens (kalifilcon A)

Singapore flagSingapore·CLASS B·Bausch & Lomb Incorporated·Registered October 24, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0508597
Registration Date
October 24, 2023
Retention Due Date
October 23, 2025
Product description
The Bausch + Lomb Ultra One Day for Astigmatism Contact Lens (kalifilcon A) is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) and reduction of spherical aberration in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
Product Owner
Name
Bausch & Lomb Incorporated
Short Name
Bausch & Lomb
Address
1400 North Goodman Street, Rochester, NY 14609, UNITED STATES
Registrant
Name
BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Importer
Name
BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Model information
Model Name(s)
Bausch + Lomb Ultra One Day for Astigmatism Contact Lens (Spherical Power: -20.00D to +20.00D, in 0.25D incremental step), (Cylinder power: -0.75D to -5.00D, in 0.50D increment step), (pack of 5, 30 and 90)
Model Identifier(s)
Ultra One Day Astigmatism
About this record

Access comprehensive regulatory information for Bausch + Lomb Ultra One Day for Astigmatism Contact Lens (kalifilcon A) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508597 and owned by Bausch & Lomb Incorporated. The device was registered on October 24, 2023.

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