AGFA

AGFA

Address:Septestraat 27,Mortsel Antwerpen,BE

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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, mammographic (IZH) (8) Cassette, radiographic film (IXA) (1) Film, radiographic (IWZ) (1)

Premarket Exempt

No Yes

Clear

CURIX ORTHO REGULAR - 05414904006511 Catalog Number : 38XZ8

Device Description : CURIX CAS EU+OR REG 15X30

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

M Plus - Half Blue - 05414904007846 Catalog Number : 3XAY3

Device Class :

Duns Number: 374444883

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : Yes

Device Count : 100

MAMORAY HD - 05414904008881 Catalog Number : EDBR1

Device Description : MAMORAY CASSETTE / HD

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

MAMORAY HD - 05414904008898 Catalog Number : EDBQY

Device Description : MAMORAY CASSETTE / HD

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

MAMORAY HD S - 05414904008942 Catalog Number : EDB4R

Device Description : MAMORAY CASSETTE / HD S

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

MAMORAY HD S - 05414904008959 Catalog Number : EDB3P

Device Description : MAMORAY CASSETTE / HD S

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

MAMORAY HD S - 05414904008966 Catalog Number : EDB1L

Device Description : MAMORAY CASSETTE / HD S

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

MAMORAY HD - 05414904009345 Catalog Number : EDBU7

Device Description : MAMORAY CASSETTE / HD

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

MAMORAY HD S - 05414904009796 Catalog Number : EDBZJ

Device Description : MAMORAY CASSETTE / HD S

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

MAMORAY HD - 05414904009802 Catalog Number : EDBVA

Device Description : MAMORAY CASSETTE / HD

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

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