Singapore HSA registration DE0018249
Huvitz Auto-Ref / Keratometer HRK-9000A
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
Registration information
- Registration Number
- DE0018249
- Registration Date
- June 14, 2016
- Change Notification Approval Date
- October 27, 2017
- Retention Due Date
- June 13, 2025
Product description
The Auto Ref/Keratometer HRK-9000A is intended to be used to measure the refractive power of the eye.
Product Owner
- Name
- Huvitz Co., Ltd.
- Short Name
- Huvitz Co., Ltd.
- Address
- 38, Burim-ro, 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, KOREA, REPUBLIC OF
Registrant
- Address
- 30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Importer
- Address
- 30 KAKI BUKIT CRESCENT, KAKI BUKIT TECHPARK I, SINGAPORE 416261
Model information
- Model Name(s)
- Auto Ref / Keratometer HRK-9000A RM Calibration set
- Model Identifier(s)
- HRK-9000A RMCal0001
About this record
Access comprehensive regulatory information for Huvitz Auto-Ref / Keratometer HRK-9000A in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018249 and owned by Huvitz Co., Ltd.. The device was registered on June 14, 2016.
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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