Cellavision AB

Address:Mobilvagen 12,LUND Skane,SE

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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

Device, Automated Cell-Locating (JOY) (2) Medical Device Data System (OUG) (2)

Premarket Exempt

No Yes

Clear

CellaVision® Remote Review Software, Enterprise Edition, version independent - 07350040975923 Catalog Number : CRRS-GR0099

Device Description : The CellaVision remote review software enable remote users to access data collec The CellaVision remote review software enable remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

DI Remote Review Software version 6.x.x - 07350040975930 Catalog Number : AG516335

Device Description : The CellaVision remote review software enable remote users to access data collec The CellaVision remote review software enable remote users to access data collected, stored and processed by DI-60 with the ability to reclassify cells and sign off slides from another location.

Device Class : 2

Duns Number: 508663101

Premarket Exempt : No

Product Code : JOY

Prescription Use : Yes

Device Count : 1

CellaVision® Server Softwaren Non-expiring license - 07350040975961 Catalog Number : CSS-000099

Device Description : The CellaVision Server Software is a network optimization design to create workf The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server.

Device Class : 1

Duns Number: 508663101

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

CellaVision® Server Softwaren, Upgrade to next generation - 07350040976036 Catalog Number : CSS-0000NG

Device Class : 1

Duns Number: 508663101

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

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