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

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 Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige Retina module and Pictor Prestige Anterior module.

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 Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module.

Device Class : 2

Duns Number: 401968495

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

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