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BECKMAN COULTER IRELAND INC.

Ireland·IE-MF-000000887

Last updated May 25, 2026

Information

Country: Ireland
Address: Lismeehan, Co. Clare, Ireland
Website: www.beckmancoulter.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +353 65 6831100
PRRC Contact: Marguerita Sweeney
EUDAMED SRN: IE-MF-000000887
FDA FEI Number: —
DUNS Number: 985071975

Catalogue (135)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Au Bicarbonate Reagent	K131546	FDA 510(k)	Class II	Active
Beta-2-Microglobulin	K161297	FDA 510(k)	Class II	Active
Ceruloplasmin	K161508	FDA 510(k)	Class II	Active
iQ Body Fluids Conical Tubes	800-3215	EUDAMEDFDA UDI	Class A	Active
(8C 2L) Navios EX Instrument	B80911	EUDAMEDFDA UDI	Class A	Active
Myoglobin	ODR3025	EUDAMED	Class B	Active
SW Kit; Navios EX Offline 5 Users (Win 10)	C48622	EUDAMED	Class A	Active
Eddp	OSR6318	EUDAMED	Class B	Active
Aquios Flow Count 100 test	B43611	EUDAMED	Class C	Active
Digoxin	OSR6404	EUDAMED	Class C	Active
iQ Lamina	800-3236	EUDAMEDFDA UDI	Class A	Active
ITA Control Serum Level 3	ODC0016	EUDAMED	Class C	Active
Digitoxin	OSR6403	EUDAMED	Class C	Active
SW offline 5 users (Navios EX)	B91239	EUDAMEDFDA UDI	Class A	Active
Urine/CSF Albumin Calibrator	B38859	EUDAMEDFDA UDI	Class B	Active
Aquios Sheath Solution	B25697	EUDAMEDFDA UDI	Class A	Active
ClearLLab Control Cells Abnormal	B90003	EUDAMEDFDA UDI	Class C	Active
CK-MB Calibrator	ODR30034	EUDAMED	Class C	Active
ISE Low/High Urine Standard	66315	EUDAMED	Class B	Active
a-1-ANTITRYPSIN	OSR6163	EUDAMEDFDA UDI	Class B	Active
Control Serum Level 1	ODC0003	EUDAMED	Class C	Active
DxH 500 Series Lyse	B36846	EUDAMEDFDA 510(k)FDA UDI	Class A	Active
iChemVELOCITY Wash Solution	800-7217	EUDAMEDFDA UDI	Class A	Active
AQUIOS PLG Software	B87334	EUDAMED	Class C	Active
ISE Na+/K+ Selectivity Check	66313	EUDAMED	Class B	Active
HDL Cholesterol Calibrator	ODC0011	EUDAMED	Class B	Active
AQUIOS Immuno-Trol Low Cells	B25700	EUDAMEDFDA UDI	Class C	Active
AQUIOS PLG Panel 50 Test	B42535	EUDAMED	Class C	Active
HDL Cholesterol	OSR6687	EUDAMEDFDA UDI	Class B	Active
ISE Low Serum Standard	66317	EUDAMED	Class B	Active
Iris	660-3021	EUDAMEDFDA UDI	Class A	Active
iQ Body Fluids Lysing Reagent	800-3213	EUDAMEDFDA UDI	Class A	Active
ClearLLab M1 Cell tube	B96807	EUDAMEDFDA UDI	Class C	Active
CK-MB Control Serum Level 2	ODR30036	EUDAMED	Class C	Active
Aquios Instrument	C23962	EUDAMED	Class A	Active
Iris System Cleanser	800-3203	EUDAMEDFDA UDI	Class A	Active
HDL/LDL Cholesterol Control Serum	ODC0005	EUDAMED	Class B	Active
(10C 3L) Navios EX Instrument	B80910	EUDAMEDFDA UDI	Class A	Active
ITA Control Serum Level 2	ODC0015	EUDAMED	Class C	Active
Digoxin Calibrator	ODC6404	EUDAMED	Class C	Active
Control Serum Level 2	ODC0004	EUDAMED	Class C	Active
Ldh	OSR6128	EUDAMED	Class B	Active
AQUIOS Immuno-Trol Cells	B23535	EUDAMEDFDA UDI	Class C	Active
HDL Cholesterol	OSR6187	EUDAMED	Class B	Active
Bicarbonate Calibrator	ODC0019	EUDAMEDFDA UDI	Class B	Active
AQUIOS ImmunoTrol Cells (Tetra/PLG)	B45229	EUDAMED	Class C	Active
Alpha-amylase	OSR6182	EUDAMED	Class B	Active
Cleaning Solution (for Contamination Avoidance)	ODR20067	EUDAMED	Class A	Active
DxH 500 Series Diluent	B36845	EUDAMEDFDA UDI	Class A	Active
FlowClean Cleaning Agent	C48093	EUDAMED	Class A	Active

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