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Singapore HSA registration DE0505927

Crystalvue Crystalvue Automated Portable Retinal Camera NFC-600

Singapore flagSingapore·CLASS B·Crystalvue Medical Corporation·Registered June 24, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration information
Registration Number
DE0505927
Registration Date
June 24, 2021
Retention Due Date
June 23, 2025
Product description
NFC-600 provides non-mydriatic color retina and external images of the eye as an aid to clinicians in the evaluation and diagnosis of eye disease. NFC-600, 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. NFC-600 is also not intended to be used as the sole diagnostic aid in disease identification, classification, or management.
Product Owner
Name
Crystalvue Medical Corporation
Short Name
Crystalvue Medical Corporation
Address
No.116, Ln.956, Zhongshan Rd.,, Taoyuan Dist., Taoyuan City 33072, TAIWAN
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)
Crystalvue NFC-600
Model Identifier(s)
700-C2701-001
About this record

Access comprehensive regulatory information for Crystalvue Crystalvue Automated Portable Retinal Camera NFC-600 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505927 and owned by Crystalvue Medical Corporation. The device was registered on June 24, 2021.

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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