Aesku.Systems GmbH & Co. KG

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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

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (DHN) (2) Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use (PIV) (2) Station, Pipetting And Diluting, For Clinical Use (JQW) (2)

Premarket Exempt

No Yes

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HELMED - 04260186125003 Catalog Number : HEL-1000

Device Description : Automated IFA Processor

Device Class : 1

Duns Number: 341702675

Premarket Exempt : Yes

Product Code : JQW

Prescription Use : No

Device Count : 1

HELIOS - 04260186125096 Catalog Number : IOS-1000

Device Description : Automated system for immunofluorescence processing with an integral fluorescence Automated system for immunofluorescence processing with an integral fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.

Device Class : 2

Duns Number: 341702675

Premarket Exempt : No

Product Code : PIV, DHN

Prescription Use : Yes

Device Count : 1

HELMED - 42601861205007 Catalog Number : HEL-1000

Device Description : Automated IFA Processor

Device Class : 1

Duns Number: 341702675

Premarket Exempt : Yes

Product Code : JQW

Prescription Use : No

Device Count : 1

HELIOS - 42601861205090 Catalog Number : IOS-1000

Device Description : Automated system for immunofluorescence processing with an integrated fluorescen Automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions.

Device Class : 2

Duns Number: 341702675

Premarket Exempt : No

Product Code : DHN, PIV

Prescription Use : Yes

Device Count : 1

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