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

Cassette, radiographic film (IXA) (7) Solid state x-ray imager (flat panel/digital imager) (MQB) (2) Film, radiographic (IWZ) (1)

Premarket Exempt

Yes No

Clear

CR MD4.0 GENERAL CASSETTE - 05414904029213 Catalog Number : 37POD

Device Description : CR MD4.0 GENERAL CASS HR 18X24

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL CASSETTE - 05414904029220 Catalog Number : 37PPF

Device Description : CR MD4.0 GENERAL CASS HR 15X30

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

M Plus - Half Blue - 05414904031742 Catalog Number : EKYFH

Device Class :

Duns Number: 374444883

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : Yes

Device Count : 25

CURIX ORTHO MEDIUM - 05414904032961 Catalog Number : 3KNPU

Device Description : CURIX CAS EU+OR MED 18X43

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

CURIX ORTHO MEDIUM - 05414904032985 Catalog Number : 3KNRY

Device Description : CURIX CAS EU+OR MED 24X30

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

CURIX ORTHO MEDIUM - 05414904032992 Catalog Number : 3KNS1

Device Description : CURIX CAS EU+OR MED 30X40

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

CURIX ORTHO MEDIUM - 05414904033005 Catalog Number : 3KNT3

Device Description : CURIX CAS EU+OR MED 35X35

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

CURIX ORTHO MEDIUM - 05414904033012 Catalog Number : 3KNU5

Device Description : CURIX CAS EU+OR MED 35X43

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

CURIX ORTHO REGULAR - 05414904033029 Catalog Number : 3KOA4

Device Description : CURIX CAS EU+OR REG 35X35

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

CURIX ORTHO REGULAR - 05414904033036 Catalog Number : 3KOB6

Device Description : CURIX CAS EU+OR REG 35X43

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

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