VISIONFLEX PTY. LTD.

Address:1/8 Prosperity Parade Warriewood,Sydney New South Wales,AU

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Filters

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

Medical Device Data System (OUG) (9) Camera, Television, Surgical, Without Audio (FWB) (1)

Premarket Exempt

No Yes

Clear

Visionflex - 09352527000553 Catalog Number :

Device Description : The ProEX Imaging Hub is specifically designed and engineered to enable health p The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all over the world to confidently carry out detailed medical examinations on patients based in regional, remote, rural and urban areas.

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

Visionflex - 09352527000560 Catalog Number :

Device Description : ProEX Telehealth Hub System FSC2 PAL - CLINICIAN v2

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

Visionflex - 09352527000577 Catalog Number :

Device Description : ProEX Telehealth Hub System GEIS - CLINICIAN v2

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

Visionflex - 09352527000584 Catalog Number :

Device Description : ProEX Telehealth Hub System FSC2 - NTSC - CLINICIAN v2

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

Visionflex - 09352527000591 Catalog Number :

Device Description : ProEX Telehealth Hub System FSC2 CUSTOMER SUPPLIED - CLINICIAN v2

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

Visionflex - 09352527000607 Catalog Number :

Device Description : ProEX Telehealth Hub System FSC3 CLINICIAN v2

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

Visionflex - 09352527000614 Catalog Number :

Device Description : ProEX Telehealth Hub System Standard - CLINICIAN v3

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

Visionflex - 09352527000669 Catalog Number :

Device Description : ProEX Mobile Telehealth Hub

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : OUG

Prescription Use : No

Device Count : 1

Visionflex - 09352527000775 Catalog Number :

Device Description : GEIS Camera (General Examination Imaging System) is a handheld device that can c GEIS Camera (General Examination Imaging System) is a handheld device that can capture medical grade quality images and video in Full HD 1080p resolution at the touch of a button.

Device Class :

Duns Number: 752219480

Premarket Exempt : No

Product Code : FWB

Prescription Use : No

Device Count : 1

Visionflex - 09352527001161 Catalog Number :

Device Description : ProEX Telehealth Hub System Standard - CLIN - v3

Device Class : 1

Duns Number: 752219480

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

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