Singapore HSA registration DE0012808
Crystalvue FundusVue® Non-Mydriatic Fundus Camera
Singapore·CLASS B·Crystalvue Medical Corporation·Registered April 29, 2013Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ophthalmology
- HSA Product Code
- HSAMDB00108
- HS Code
- 90185000
Registration information
- Registration Number
- DE0012808
- Registration Date
- April 29, 2013
- Change Notification Approval Date
- August 29, 2018
- Retention Due Date
- April 28, 2026
Product description
FundusVue® provides non-mydriatic color posterior chamber and external images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. FundusVue® , which uses NIR LED as illumination during alignment to the retina of patients’ eyes, provides images only and does not provide any diagnostic or pathological analysis or conclusions in any way. FundusVue® is also not intended to be used as the sole diagnostic aid in disease identification, classification or management.
Product Owner
- Short Name
- Crystalvue Medical Corporation
- Address
- No.116, Ln.956, Zhongshan Rd.,, Taoyuan Dist., Taoyuan City 33072,, TAIWAN
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)
- Power adapter X-Y-Z Controller Camera Head
- Model Identifier(s)
- 600-C0202-001 700-C0102-001 700-C0201-C01
About this record
Access comprehensive regulatory information for Crystalvue FundusVue® Non-Mydriatic Fundus Camera in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0012808 and owned by Crystalvue Medical Corporation. The device was registered on April 29, 2013.
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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