MEDIMAGING INTEGRATED SOLUTION INC.

Address:3F, No.24-2, Industry E. Rd. IV,,Hsinchu Hsinchu (City),TW

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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

Camera, Ophthalmic, General-Use (PJZ) (6)

Premarket Exempt

Yes

Clear

Welch Allyn - 04719872711117 Catalog Number :

Device Description : Eye Fundus Camera: RetinaVue 100 Imager (RV100PROC)

Device Class : 2

Duns Number: 656813438

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Welch Allyn - 04719872711124 Catalog Number :

Device Description : Eye Fundus Camera: RetinaVue 100 Imager (RV100PRO-C)

Device Class : 2

Duns Number: 656813438

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Welch Allyn - 04719872711131 Catalog Number :

Device Description : Eye Fundus Camera: RetinaVue 700 Imager (RV700B)

Device Class : 2

Duns Number: 656813438

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Welch Allyn - 04719872711148 Catalog Number :

Device Description : Eye Fundus Camera: RetinaVue 700 Imager (RV700TU-B)

Device Class : 2

Duns Number: 656813438

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Welch Allyn - 04719872711155 Catalog Number :

Device Description : Eye Fundus Camera: RetinaVue 700 Imager (RV700TUD-B)

Device Class : 2

Duns Number: 656813438

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

Welch Allyn - 04719872711162 Catalog Number :

Device Description : Eye Fundus Camera: RetinaVue 700 Imager (RV700-B)

Device Class : 2

Duns Number: 656813438

Premarket Exempt : Yes

Product Code : PJZ

Prescription Use : Yes

Device Count : 1

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