EKF-diagnostic GmbH

Address:EBENDORFER CHAUSEE 3,BARLEBEN/MADGEBURG Saxony-Anhalt,DE

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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

System, Hemoglobin, Automated (GKR) (5) Control, Hemoglobin (GGM) (4) Whole Blood Hemoglobin Determination (KHG) (2) Calculator/Data Processing Module, For Clinical Use (JQP) (1)

Premarket Exempt

No Yes

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Hemo Control Hemoglobin Microcuvette - 04048534000031 Catalog Number : 3000-3012-0765

Device Description : For the quantitative determination of hemoglobin in whole blood.

Device Class : 2

Duns Number: 330046442

Premarket Exempt : No

Product Code : GKR, KHG

Prescription Use : Yes

Device Count : 50

DiaSpect Tm - 04048534001946 Catalog Number : 900-001

Device Description : For the quantitative determination of hemoglobin in whole blood.

Device Class : 2

Duns Number: 330046442

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

DiaSpect Control HBT4 - 04048534002004 Catalog Number : 900-504

Device Description : For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes

Device Class : 2

Duns Number: 330046442

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 1

EKF Link - 04048534002011 Catalog Number : 0760-0101

Device Description : EKF Link is a data and device management system that enables healthcare professi EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes.EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link.EKF Link facilitates the setting of configurable options of connected analyzers.

Device Class : 1

Duns Number: 330046442

Premarket Exempt : Yes

Product Code : JQP

Prescription Use : No

Device Count : 1

Hemo Control - 04048534002028 Catalog Number : 3040-0010-0218

Device Description : For the quantitative determination of hemoglobin in whole blood.

Device Class : 2

Duns Number: 330046442

Premarket Exempt : No

Product Code : GKR, KHG

Prescription Use : Yes

Device Count : 1

DiaSpect Tm - 04048534002165 Catalog Number : 900-001

Device Description : For the quantitative determination of hemoglobin in whole blood.

Device Class : 2

Duns Number: 330046442

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

DiaSpect Tm Cuvettes - 14048534001967 Catalog Number : 900-500

Device Description : For the quantitative determination of hemoglobin in whole blood.

Device Class :

Duns Number: 330046442

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 500

DiaSpect Control HBT1 - 14048534001974 Catalog Number : 900-501

Device Description : For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes

Device Class : 2

Duns Number: 330046442

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 3

DiaSpect Control HBT2 - 14048534001981 Catalog Number : 900-502

Device Description : For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes

Device Class : 2

Duns Number: 330046442

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 3

DiaSpect Control HBT3 - 14048534001998 Catalog Number : 900-503

Device Description : For the verification of the precision and accuracy of DiaSpect Tm and DiaSpect Tm Cuvettes

Device Class : 2

Duns Number: 330046442

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : Yes

Device Count : 3

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