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

Solid state x-ray imager (flat panel/digital imager) (MQB) (8) Film, radiographic (IWZ) (2)

Premarket Exempt

Yes No

Clear

M Plus - Half Blue - 05414904028605 Catalog Number : 3XA7L

Device Class :

Duns Number: 374444883

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : Yes

Device Count : 100

M Plus - Half Blue - 05414904028612 Catalog Number : 3XAWY

Device Class :

Duns Number: 374444883

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : Yes

Device Count : 100

CR MD4.0 GENERAL CASSETTE - 05414904028971 Catalog Number : 37PQH

Device Description : CR MD4.0 GENERAL CASS HR 8X10I

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL CASSETTE - 05414904028988 Catalog Number : 37PRK

Device Description : CR MD4.0 GENERAL CASS HR 10X12I

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL CASSETTE - 05414904028995 Catalog Number : 37PSM

Device Description : CR MD4.0 GENERAL CASS SR 35X43

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL CASSETTE - 05414904029008 Catalog Number : 37PTO

Device Description : CR MD4.0 GENERAL CASS HR 35X43

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL CASSETTE - 05414904029015 Catalog Number : 37PUQ

Device Description : CR MD4.0 GENERAL CASS SR 35X35

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL CASSETTE - 05414904029022 Catalog Number : 37PVS

Device Description : CR MD4.0 GENERAL CASS HR 35X35

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL CASSETTE - 05414904029039 Catalog Number : 37PWU

Device Description : CR MD4.0 GEN CASS PS SYM 35X43

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL CASSETTE - 05414904029206 Catalog Number : 37PNB

Device Description : CR MD4.0 GENERAL CASS HR 24X30

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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