Arcoma AB

Address:ANNAVAGEN 1,VAXJO Kronoberg,SE

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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, Stationary (KPR) (3) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (2) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (1)

Premarket Exempt

No Yes

Clear

OMNERA 400A - 07350008750012 Catalog Number :

Device Description : Stationary x-ray system intended for obtaining radiographic images portions of t Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.

Device Class : 2

Duns Number: 356774109

Premarket Exempt : Yes

Product Code : MQB, KPR

Prescription Use : No

Device Count : 1

OMNERA 400T - 07350008750050 Catalog Number :

Device Description : Stationary x-ray system intended for obtaining radiographic images of various po Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.

Device Class : 2

Duns Number: 356774109

Premarket Exempt : Yes

Product Code : MQB, KPR

Prescription Use : No

Device Count : 1

OMNERA 500A - 07350008750098 Catalog Number :

Device Class : 2

Duns Number: 356774109

Premarket Exempt : No

Product Code : MOB, KPR

Prescription Use : No

Device Count : 1

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