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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 1 of 3

Device	Model / Reference	Registries	Class	Status
Au	DR0070-2	FDA UDI	Class II	Active
ClearLLab	B2	FDA UDI	Class II	Active
iQ®200	iQ® Calibrator	FDA UDI	Class I	Active
Navios EX	TETRA SOFTWARE V2.0 NEW USER	FDA UDI	Class II	Active
Navios Analysis Software	774953	FDA UDI	Class II	Active
StatSpin	X00-004998-001	FDA UDI	Class II	Active
ClearLLab	B1	FDA UDI	Class II	Active
IRISpec	CA/CB/CC URINE CHEMSITRY CONTROLS	FDA UDI	Class I	Active
iChem Velocity	Elite/Stand-Alone Velocity (NA)	FDA UDI	Class I	Active
DxH 500	B40601	FDA UDI	Class II	Active
iChem® VELOCITY™	CalChek Kit	FDA UDI	Class I	Active
iChem Velocity	Back-Integrated Velocity (NA)	FDA UDI	Class I	Active
iQ®200	Body Fluids Module	FDA UDI	Class II	Active
Au	DR0070-1	FDA UDI	Class II	Active
UA Win10 Kit	C52900	FDA UDI	Class I	Active
DxH 500 Series Calibrator	B36880	FDA UDI	Class II	Active
Navios tetra Software	775213	FDA UDI	Class II	Active
iQ®200	iQ® Body Fluids Controls-Level I and Level II (NA/INTL)	FDA UDI	Class II	Active
Navios	10 Color 3 lasers	FDA UDI	Class II	Active
Navios	8 Color 2 lasers	FDA UDI	Class II	Active
ClearLLab	T2	FDA UDI	Class II	Active
Navios Analysis Software	774952	FDA UDI	Class II	Active
ClearLLab	T1	FDA UDI	Class II	Active
IRISpec	CA/CB/CC URINE CHEMSITRY CONTROLS	FDA UDI	Class I	Active
ClearLLab	M	FDA UDI	Class II	Active
DxH 520	B40602	FDA UDI	Class II	Active
Au	OSR6167	FDA UDI	Class II	Active
iQ200	Select Plus Kit 2008 Analyzer (NA)/ Select Pro (NA)	FDA UDI	Class I	Active
iQ®200	iQ® Control/Focus Set (NA/INTL)	FDA UDI	Class I	Active
Navios Analysis Software	774951	FDA UDI	Class II	Active
iQ200	Sprint Pro (NA)/SPRINT w load/unload (NA)/SPRINT Pro w load/unload (NA)/Sprint P	FDA UDI	Class I	Active
Navios	6 Color 2 lasers	FDA UDI	Class II	Active
iQ200	Elite Plus (US) (2008 Version) (NA)	FDA UDI	Class I	Active
DxH 500 Series Control	B36872	FDA UDI	Class II	Active
iChem® VELOCITY™	iChem VELOCITY Urine Chemistry Strips	FDA UDI	Class I	Active
iQ®200	iQ Precision Kit	FDA UDI	Class I	Active
iQ200	Select/Elite Pro (NA)	FDA UDI	Class I	Active
ClearLLab T Cell tube	B96806	EUDAMEDFDA UDI	Class C	Active
ClearLLab M2 Cell tube	B96808	EUDAMEDFDA UDI	Class C	Active
ISE High Serum Standard	66316	EUDAMED	Class B	Active
DAU Negative Calibrator	ODC6314	EUDAMED	Class B	Active
Iris Diluent	800-3202	EUDAMEDFDA UDI	Class A	Active
SW Navios EX v2.1	C33300	EUDAMED	Class A	Active
Myoglobin	OSR6168	EUDAMED	Class B	Active
Ise Buffer	66320	EUDAMED	Class B	Active
ClearLLab Compensation Beads	B99883	EUDAMEDFDA UDI	Class C	Active
ISE Internal Reference	66314	EUDAMED	Class B	Active
CK-MB Control Serum Level 1	ODR30035	EUDAMED	Class C	Active
DAU Intermediate Multi-Drug Calibrator	ODC6317	EUDAMED	Class B	Active
AQUIOS PLG Panel 400 Test	B43610	EUDAMED	Class C	Active

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