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Singapore HSA registration DE0509661

BIO Optics BIO Plug

Singapore flagSingapore·CLASS D·BIO Optics Co., Ltd·Registered August 16, 2024
Device classification
Device Class
CLASS D
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0509661
Registration Date
August 16, 2024
Retention Due Date
August 15, 2025
Product description
BIO Plug is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to: - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface disease, - Temporarily enhance the efficacy of topical medications or ocular lubricants, - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery, and - Determine the potential effectiveness of permanent occlusion
Product Owner
Name
BIO Optics Co., Ltd
Short Name
BIO Optics Co., Ltd
Address
No.1215 SK V1 Tower, Build A, Galmachi-Str 288-14, 13201, Jungwon-gu, Seongnam-si, Gyeonggi-do, KOREA, REPUBLIC OF
Registrant
Name
RXILIENT MEDICAL PTE LTD
Address
1 COLEMAN STREET, THE ADELPHI, #08-01, SINGAPORE 179803
Importer
Name
RXILIENT MEDICAL PTE LTD
Address
1 COLEMAN STREET, THE ADELPHI, #08-01, SINGAPORE 179803
Model information
Model Name(s)
BIO Plug 0.3mm BIO Plug 0.4mm BIO Plug 0.5mm
Model Identifier(s)
BIOPLUG-0.3 BIOPLUG-0.4 BIOPLUG-0.5
About this record

Access comprehensive regulatory information for BIO Optics BIO Plug in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509661 and owned by BIO Optics Co., Ltd. The device was registered on August 16, 2024.

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 D