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) (10) X-Ray, Tomography, Computed, Dental (OAS) (8)

Premarket Exempt

Clear

X-MIND prime 3D - D804W12000050 Catalog Number : W1200005

Device Description : X-MIND prime 3D wall version open range including WS and Monitor

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

X-MIND prime 3D - D804W12000070 Catalog Number : W1200007

Device Description : X-MIND prime 3D column version open range including WS and Monitor

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : MUH, OAS

Prescription Use : Yes

Device Count : 1

X-MIND prime - D804W12000090 Catalog Number : W1200009

Device Description : X-MIND prime CEPH version open range

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

X-MIND prime - D804W1200009DS0 Catalog Number : W1200009.DS

Device Description : X-MIND prime CEPH version with double sensor open range

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : MUH

Prescription Use : Yes

Device Count : 1

X-MIND prime 3D - D804W12000100 Catalog Number : W1200010

Device Description : X-MIND prime 3D CEPH version open range including WS and Monitor

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : MUH, OAS

Prescription Use : Yes

Device Count : 1

U-SENSE - D804W13000010 Catalog Number : W1300001

Device Description : Intraoral Sensor U-SENSE size T1 (W1300001)

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

U-SENSE - D804W13000020 Catalog Number : W1300002

Device Description : Intraoral Sensor U-SENSE size T2 (W1300002)

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

U-SENSE HD - D804W13000030 Catalog Number : W1300003

Device Description : Intraoral Sensor U-SENSE HD size T1 (W1300003)

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

U-SENSE HD - D804W13000040 Catalog Number : W1300004

Device Description : Intraoral Sensor U-SENSE HD size T2 (W1300004)

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

xgenus Vega - D804W13050010 Catalog Number : W1305001

Device Description : Intraoral Sensor xgenus Vega size T1 (W1305001)

Device Class : 2

Duns Number: 433051802

Premarket Exempt : No

Product Code : OAS, MUH

Prescription Use : Yes

Device Count : 1

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