FONA SRL

Address:VIA GALILEI 11,ASSAGO Milano,IT

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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

System, X-Ray, Extraoral Source, Digital (MUH) (4) Unit, X-Ray, Extraoral With Timer (EHD) (2)

Premarket Exempt

Clear

IntraOs 70 - E31593202013000 Catalog Number :

Device Description : Intraoral X-ray unit (70 kV, 7 mA), sensor not included

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

IntraOs DG - E31593250013000 Catalog Number :

Device Description : Intraoral X-ray unit (70 kV, 3.5 mA), sensor not included

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : EHD

Prescription Use : Yes

Device Count : 1

StarX-1 - E31593800001000 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

StarX-2 - E31593800002000 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

StarX PRO-1 - E31593800011000 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

StarX PRO-2 - E31593800012000 Catalog Number :

Device Class : 2

Duns Number: 514320345

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

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