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Bausch + Lomb Stellaris Elite Procedure Packs - HSA Registration DE0502809

Access comprehensive regulatory information for Bausch + Lomb Stellaris Elite Procedure Packs in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502809 and owned by Bausch & Lomb Inc.. The device was registered on February 26, 2019.

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
DE0502809
Bausch + Lomb Stellaris Elite Procedure Packs
HSA Registration Number: DE0502809
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Product Description

The Posterior Vitrectomy Packs are intended for use with a Bausch + Lomb Microsurgical Systemโ„ข for vitrectomy during posterior segment surgery. The Combined Vitrectomy Cutter Packs are intended for use with a Bausch & Lombยฎ Microsurgical System for both vitrectomy during posterior segment surgery and for phacoemulsification of an opacified crystalline lens during anterior segment surgery. The ultrasound needles/Adaptive Fluidics Packs are intended for use with a Bausch & Lomb Microsurgical System for the emulsification of an opacified crystalline lens.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0502809
Registration Date
February 26, 2019
Change Notification Approval Date
July 01, 2024
Retention Due Date
February 25, 2026
Product Owner
Short Name
Bausch & Lomb Inc.
Address
1400 North Goodman Street, Rochester, NY 14609, UNITED STATES
Registrant
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Importer
Address
3 HARBOURFRONT PLACE, HARBOURFRONT TOWER TWO, #09-04, SINGAPORE 099254
Model Information
Model Name(s)
Adaptive Fluidics Infusion Technology Premium Pack Adaptive Fluidics Infusion Technology Standard Pack Adaptive Fluidics Infusion Technology Premium MICS Pack Adaptive Fluidics Infusion Technology Basic Pack Stellaris Elite 20 GA. Vit Cutter, 7500 cpm Needle Microflow 30 Degree Sterile Needle Microflow 2.2 30 Degree Sterile 23 Ga. Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris Elite Pack 23 ga. Posterior Wide-Field Elite Pack 23 Ga. Bi-Blade Vitreous Cutter Posterior Wide-Field Stellaris Elite Pack 25 ga. Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris Elite Pack 25 ga. Posterior Wide-Field Elite Pack 25 ga. Bi-Blade Vitreous Cutter Posterior Wide-Field Stellaris Elite Pack 27 ga. Bi-Blade Vitreous Cutter Posterior Mid-Field Stellaris Elite Pack 20 ga. Combined Wide-Field Elite Pack 23 ga. Combined Mid-Field Elite Pack 23 Ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack 23 ga. Combined Wide-Field Elite Pack 23 Ga. Bi-Blade Vitreous Cutter Combined Wide-Field Stellaris Elite Pack 25 ga. Combined Mid-Field Elite Pack 25 ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack 25 ga. Combined Wide-Field Elite Pack 25 ga. Bi-Blade Vitreous Cutter Combined Wide-Field Stellaris Elite Pack 27 ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack Stellaris Elite PC 20 GA Anterior Vitrectomy 23 GA. Stellaris Elite Vitrectomy Probe Stellaris Elite PC 23 GA Anterior Vitrectomy 23 ga. Bi-Blade Vitrectomy Cutter, 7500 cpm 25 GA. Stellaris Elite Vitrectomy Probe Stellaris Elite 25 GA. Bi-Blade Vit Cutter Stellaris Elite 27 GA. Bi-Blade Vit Cutter
Model Identifier(s)
BL5115-1 BL5115-2 BL5115-3 BL5115-4 BL5626 DP8230S DP8730S SE5423MVB SE5423WV SE5423WVB SE5425MVB SE5425WV SE5425WVB SE5427MVB SE5520W SE5523MV SE5523MVB SE5523WV SE5523WVB SE5525MV SE5525MVB SE5525WV SE5525WVB SE5527MVB SE5620AV SE5623 SE5623AV SE5623B SE5625 SE5625B SE5627B