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EKF-diagnostic GmbH

US

Last updated May 30, 2026

Information

Country: US
Address: —
Website: ekf-diagnostic.de
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +4939203511414
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 330046442

Catalogue (17)

Device	Model / Reference	Registries	Class	Status
DiaSpect Tm	7049-0013-0264	FDA UDI	Class II	Active
DiaSpect Control HBT4	7049-6214	FDA UDI	Class II	Active
Add Pack Hemo Control DM	3040-7201-0099	FDA UDI	Class II	Active
DiaSpect Control HBT1	7049-6211	FDA UDI	Class II	Active
DiaSpect Control HBT3	7049-6213	FDA UDI	Class II	Active
DiaSpect Tm Cuvettes	7049-3013-0369	FDA UDI	Class II	Active
Hemo Control	3040-0010-0218	FDA UDI	Class II	Active
EKF Link	0760-0101	FDA UDI	Class I	Active
Cleaner	3000-6232	FDA UDI	Class II	Active
Hemo Control Hemoglobin Microcuvette	3000-3012-0765	FDA UDI	Class II	Active
DiaSpect Tm	7049-0013-0264	FDA UDI	Class II	Active
DiaSpect Control HBT2	7049-6212	FDA UDI	Class II	Active
Hemo Control (optional Add Pack Hemo Control DM)	K200909	FDA 510(k)	Class II	Active
DiaSpect Tm, DiaSpect Tm Cuvettes	K172173	FDA 510(k)	Class II	Active
Quo-Test A1c System	K180509	FDA 510(k)	Class II	Active
Ekf- Diagnostic Hemo_control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin Microcuvettes (modified Curvette W	K110393	FDA 510(k)	Class II	Active
Ekf Diagnostic Hemo Control Hemoglobin Measurement System	K031898	FDA 510(k)	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Ekf Diagnostic Gmbh BARLEBEN/MADGEBURG Saxony-Anhalt · DE FEI 3004838836