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Hemocue, Inc.

Last updated May 23, 2026

Information

Country: US
Address: —
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FDA FEI Number: —
DUNS Number: —

Catalogue (46)

Device	Model / Reference	Registries	Class	Status
HemoCue® Hb 201 DM Analyzer	121146	FDA UDI	Class II	Active
HemoCue® Plasma/Low Hb Photometer	120314	FDA UDI	Class II	Active
HemoCue® Hb 201 Microcuvettes	111732	FDA UDI	Class II	Active
HemoCue® Glucose 201 Analyzer	120707	FDA UDI	Class II	Active
HemoCue® Glucose 201 DM Analyzer	121444	FDA UDI	Class II	Active
HemoCue® WBC Analyzer	123001	FDA UDI	Class II	Active
HemoCue® Hb 201 DM Analyzer	121135	FDA UDI	Class II	Active
HemoCue® Glucose 201 Analyzer	120706	FDA UDI	Class II	Active
HemoCue® Albumin 201 Analyzer	120623	FDA UDI	Class I	Active
HemoCue® Hb 301 Microcuvettes	111801	FDA UDI	Class II	Active
HemoCue® Hb 801 Microcuvettes	111902	FDA UDI	Class II	Active
HemoCue® Glucose 201 Microcuvettes	110723	FDA UDI	Class II	Active
HemoCue® Urine Albumin Microcuvettes	110608	FDA UDI	Class I	Active
HemoCue® Glucose 201 DM Analyzer	121422	FDA UDI	Class II	Active
HemoCue® Hb 301 Microcuvettes	111807	FDA UDI	Class II	Active
HemoCue® Hb 301 Microcuvettes	111812	FDA UDI	Class II	Active
HemoCue® Hb301 Analyzer	121827	FDA UDI	Class II	Active
HemoCue® Hb 201 Microcuvettes	111731	FDA UDI	Class II	Active
HemoCue® Glucose 201 Microcuvettes	110706	FDA UDI	Class II	Active
HemoCue® Hb 801 Analyzer	121920	FDA UDI	Class II	Active
HemoCue® Hb 201+ Analyzer	121720	FDA UDI	Class II	Active
HemoCue® Hb 201 Microcuvettes	111715	FDA UDI	Class II	Active
HemoCue® Plasma/Low Hb Microcuvettes	110302	FDA UDI	Class II	Active
HemoCue® Hb 201+ Analyzer	121721	FDA UDI	Class II	Active
HemoCue® Hb 201 Microcuvettes	111716	FDA UDI	Class II	Active
HemoCue® Hb 301 Microcuvettes	111809	FDA UDI	Class II	Active
HemoCue® Hb301 Analyzer	121804	FDA UDI	Class II	Active
HemoCue® Glucose 201 Microcuvettes	110705	FDA UDI	Class II	Active
HemoCue® Hb 301 Microcuvettes	111814	FDA UDI	Class II	Active
HemoCue® 801 Connect	139168	FDA UDI	Class I	Unknown
HemoCue® WBC Microcuvettes	113003	FDA UDI	Class II	Active
Hemocue Glucose 201 Rt Analyzer Mdl 120731, Hemocue Glucose 201 Rt Microcurettes Mdl 110712	K060765	FDA 510(k)	Class II	Active
Hemocue(r) B-Glucose Microcuvette/Photometer	K911141	FDA 510(k)	Class II	Active
HemoCue Hb 801 System	K181751	FDA 510(k)	Class II	Active
Hemocue Hb 301 Analyzer, Model 121804 And Microcuvettes, Model 111801	K061047	FDA 510(k)	Class II	Active
Hemocue Albumin 201 Analyzing System	K053253	FDA 510(k)	Class I	Active
Hemocue Hemoglobin 201dm Analyzing System	K041234	FDA 510(k)	Class II	Active
Hemocue Wbc System	K071652	FDA 510(k)	Class II	Active
Hemocue B-Glucose System	K943432	FDA 510(k)	Class II	Active
HemoCue Hb 301 System	K201217	FDA 510(k)	Class II	Active
Hemocue Glucose 201 System, Article Number 120706	K020935	FDA 510(k)	Class II	Active
Hemocue B-Hemoglobin System	K961312	FDA 510(k)	Class II	Active
Hemocue B-Glcose System	K962415	FDA 510(k)	Class II	Active
Hemocue B-Glucose System	K961311	FDA 510(k)	Class II	Active
Clinical Laboratory Analyzing System	K041230	FDA 510(k)	Class II	Active
Hemocue Hemoglobin 201 + System Article 121704	K032203	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.

Hemocue Ab ANGELHOLM Skane · SE FEI 3003044483