Singapore HSA registration DE0509133
CORNEAGEN EndoSerter
Singapore·CLASS B·CorneaGen·Registered April 04, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0509133
- Registration Date
- April 04, 2024
- Retention Due Date
- April 03, 2026
Product description
The EndoSerter is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5 mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4 mm incision during endothelial keratoplasty procedures.
Product Owner
- Name
- CorneaGen
- Short Name
- CorneaGen
- Address
- 101 North Chestnut Street Suite 303, Winston-Salem, North Carolina, 27101, UNITED STATES
Registrant
- Name
- Surgipro Pte Ltd
- Address
- 23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741
Importer
- Name
- Surgipro Pte Ltd
- Address
- 23 WOODLANDS INDUSTRIAL PARK E1, ADMIRALTY INDUSTRIAL PARK, #03-05, SINGAPORE 757741
Model information
- Model Name(s)
- ENDOSERTER
- Model Identifier(s)
- ES-1
About this record
Access comprehensive regulatory information for CORNEAGEN EndoSerter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509133 and owned by CorneaGen. The device was registered on April 04, 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.
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