CRYSTALVUE MEDICAL CORPORATION

Address:No.116, Ln.956, Zhongshan Rd.,,Taoyuan Dist.,,TW

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Camera, Ophthalmic, Ac-Powered (HKI) (5)

Premarket Exempt

Clear

NFC-700 - 04719876420053 Catalog Number : 700-C1101-031

Device Description : Non-Mydriatic Auto Fundus Camera

Device Class : 2

Duns Number: 658841648

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

RetinaStation - 04719876420060 Catalog Number : 700-C1101-231

Device Description : Non-Mydriatic Auto Fundus Camera

Device Class : 2

Duns Number: 658841648

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Polaris - 04719876420176 Catalog Number : 700-C1101-431

Device Description : Non-Mydriatic Auto Fundus Camera

Device Class : 2

Duns Number: 658841648

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

NFC-600 - 04719876420268 Catalog Number : 700-C2701-031

Device Description : Automated Portable Retinal Camera

Device Class : 2

Duns Number: 658841648

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Halo - 04719876420275 Catalog Number : 700-C2701-131

Device Description : Automated Portable Retinal Camera

Device Class : 2

Duns Number: 658841648

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

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