Optomed Oy

Optomed Oy

Address:Yrttipellontie 1,Oulu Pohjois-Pohjanmaa,FI

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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, Ac-Powered (HKI) (9)

Premarket Exempt

No

Clear

Visuscout 100 set FN - 06430046260634 Catalog Number :

Device Description : Visuscout 100 set

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Pictor M5WEY4ES2 Volk FN - 06430046260658 Catalog Number :

Device Description : Volk Pictor Plus full set

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Pictor M5WEY4 Volk FN - 06430046260672 Catalog Number :

Device Description : Volk Pictor Plus retinal set

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Optomed Aurora full set - 06430046260757 Catalog Number :

Device Description : Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module.

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Optomed Aurora retinal set - 06430046260795 Catalog Number :

Device Description : Optomed Aurora retinal set including Aurora camera and Aurora retinal module.

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Signal Camera - 06430046260832 Catalog Number :

Device Description : Ophthalmic fundus camera

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Signal set - 06430046260856 Catalog Number :

Device Description : Signal product set including Signal Camera.

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Volk Pictor Prestige full set - 06430046260870 Catalog Number :

Device Description : Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

Volk Pictor Prestige retinal set - 06430046260887 Catalog Number :

Device Description : Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Pre

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

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