DE GOTZEN SRL

Address:VIA ROMA 45,OLGIATE OLONA Varese,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) (3) X-Ray, Tomography, Computed, Dental (OAS) (3)

Premarket Exempt

Clear

xgenus Vega - D804W13050020 Catalog Number : W1305002

Device Description : Intraoral Sensor xgenus Vega size T2 (W1305002)

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

xgenus Vega HD - D804W13050030 Catalog Number : W1305003

Device Description : Intraoral Sensor xgenus Vega HD size T1 (W1305003)

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

xgenus Vega HD - D804W13050040 Catalog Number : W1305004

Device Description : Intraoral Sensor xgenus Vega HD size T2 (W1305004)

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

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