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Singapore HSA registration DE0510677

ODC Industries ErgoTouch FLY IOL Injectors

Singapore flagSingapore·CLASS B·ODC Industries·Registered May 06, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0510677
Registration Date
May 06, 2025
Retention Due Date
May 05, 2026
Product description
The ErgoTouch FLY injection system facilitates the implantation by an ophthalmic surgeon of a foldable one-piece Hydrophilic and Hydrophobic intraocular lens through incisions of between 1.8 to 2.6 mm, depending on the ErgoTouch FLY model and operating technique used. The ErgoTouch FLY injection system consists of a sterile single-use injector with silicone cushion and the single-use cartridge.
Product Owner
Name
ODC Industries
Short Name
ODC Industries
Address
Rue Thomas Edison, ZA du Bois Vert, 56800 Ploërmel, FRANCE
Registrant
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Importer
Name
Mandarin Opto-Medic Co Pte Ltd
Address
30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Model information
Model Name(s)
ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY ErgoTouch FLY
Model Identifier(s)
ET1-18 ET1-20 ET1-22 ET1-24 ET1-26 ET1-B-GMS-18-CE ET1-B-GMS-20-CE ET1-B-GMS-22-CE ET1-B-GMS-24-CE ET1-B-GMS-26-CE ET1-P-GMS-18-CE ET1-P-GMS-20-CE ET1-P-GMS-22-CE ET1-P-GMS-24-CE ET1-P-GMS-26-CE
About this record

Access comprehensive regulatory information for ODC Industries ErgoTouch FLY IOL Injectors in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510677 and owned by ODC Industries. The device was registered on May 06, 2025.

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