Singapore HSA registration DE0501492

Eye Tech Care EyeOP1 and EYEOP-PACK

Singapore flagSingapore·CLASS C·EYE TECH CARE·Registered April 09, 2018
Device classification
Device Class
CLASS C
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0501492
Registration Date
April 09, 2018
Change Notification Approval Date
April 13, 2023
Retention Due Date
April 08, 2026
Product description
This medical device (EyeOP1 control unit and associated EYEOP-PACK consumables) allows for non-invasive treatment of glaucoma via coagulation of part of the ciliary body by using focused ultrasound in order to reduce the production of aqueous humor and thereby to decrease the intraocular pressure (IOP). This treatment is called a UCP Procedure (“Ultrasound Cyclo Plasty”). This type of treatment is indicated for adult patients (over the age of 18) who are insufficiently responsive to medication and /or surgery-laser treatment and who have glaucoma characterized by ocular hypertension greater than or equal to: - 21 mmHg : for 6-sectors protocol. - 30 mmHg : for 8-sectors protocol. - 40 mmHg and no vision: for 10-sectors protocol.
Product Owner
Short Name
EYE TECH CARE
Address
2871 avenue de I`Europe, 69140 Rillieux La Pape, FRANCE
Registrant
Address
1 COLEMAN STREET, THE ADELPHI, #08-01, SINGAPORE 179803
Importer
Address
1 COLEMAN STREET, THE ADELPHI, #08-01, SINGAPORE 179803
Model information
Model Name(s)
EyeOP1 EYEOP-PACK EYEOP-PACK EYEOP-PACK EYEOP-PACK
Model Identifier(s)
ETC0200 ETC0910 ETC0911 ETC0912 ETC0913
About this record

Access comprehensive regulatory information for Eye Tech Care EyeOP1 and EYEOP-PACK in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0501492 and owned by EYE TECH CARE. The device was registered on April 09, 2018.

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 C