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SYSMEX CORPORATION

Japan·JP-MF-000014037

Last updated September 17, 2026

Information

Country: Japan
Address: 4-4-4 Takatsukadai, Nishi-ku, Kobe, Japan
Website: sysmex.co.jp
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(888)879-7644
PRRC Contact: Yasumasa Akai
EUDAMED SRN: JP-MF-000014037
FDA FEI Number: 3010421384
DUNS Number: 690664461

Catalogue (164)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
SB Cuvette II	CM500820	EUDAMED	Class A	Active
Cs-2500	BV981798	EUDAMEDFDA UDI	Class A	Active
Fluorocell WET	AA-325-279	EUDAMED	Class A	Active
Ts-10	BN168792	EUDAMED	Class A	Active
Uf-Cellsheath	BY-074-501	EUDAMEDFDA UDI	Class A	Active
St-41	AX575334	EUDAMED	Class A	Active
Pu-17	01330061	EUDAMED	Class A	Active
Cv-65	AN203513	EUDAMED	Class A	Active
HISCL Cuvette L	CP-815-570	EUDAMED	Class A	Active
Ca-660	CK978289	EUDAMEDFDA UDI	Class A	Active
Ca-650	AR822623	EUDAMED	Class A	Active
Sa-01	AZ182223	EUDAMED	Class A	Active
HISCL Diluent	CJ667474	EUDAMED	Class A	Active
Cn-6500	BH584790	EUDAMED	Class A	Active
Fluorocell WET	BJ284784	EUDAMED	Class A	Active
St-40	CJ256159	EUDAMED	Class A	Active
St-42	CV979713	EUDAMED	Class A	Active
Cellpack Dcl	CU-228-496	EUDAMED	Class A	Active
Rr-10	BC479026	EUDAMED	Class A	Active
UF-Calibrator	CN383000	EUDAMED	IVD General	Active
Urine Sample Decapper Unit	CZ583355	EUDAMED	Class A	Active
Tu-40	AN617358	EUDAMED	Class A	Active
Sa-31	AG475597	EUDAMED	Class A	Active
St-11	BD559290	EUDAMED	Class A	Active
CyFlow WA	CH647805	EUDAMED	Class A	Active
Rp-10	BL085582	EUDAMED	Class A	Active
Cellpack Dst	BM-808-974	EUDAMEDFDA UDI	Class A	Active
Cellclean U	CM-942-712	EUDAMED	Class A	Active
Cellpack Dcl	DCL-300A	EUDAMEDFDA UDI	Class A	Active
Xn Check	AE474952	EUDAMED	IVD General	Active
Lysercell WPC	CS-412-800	EUDAMEDFDA UDI	Class A	Active
Xn Check Bf	BD007680	EUDAMED	IVD General	Active
Fluorocell WDF	CV-377-552	EUDAMED	Class A	Active
RD Sample Vial	BP-675-300	EUDAMED	Class A	Active
Ru-20	CY662767	EUDAMED	Class A	Active
St-12	CU845213	EUDAMED	Class A	Active
Cellpack Dfl	AR-829-995	EUDAMEDFDA UDI	Class A	Active
Xn Check	CU248646	EUDAMED	IVD General	Active
Xn Check	AL359722	EUDAMED	IVD General	Active
Xn Cal Pf	AR511993	EUDAMED	IVD General	Active
Flow Cytometer XF-1600	AD629376	EUDAMED	Class A	Active
Ca Clean I	964-0631-3	EUDAMED	Class A	Active
Fluorocell WNR	CP-066-715	EUDAMED	Class A	Active
Rr-20	CT932479	EUDAMED	Class A	Active
Eightcheck-3wp	AQ721025	EUDAMED	IVD General	Active
Detection Cell	054-3781-8	EUDAMED	Class A	Active
CyLyse LV	BL-215-283	EUDAMED	Class A	Active
Xn Check	AN196163	EUDAMED	IVD General	Active
HISCL β-Amyloid 1-42 Assay kit	CQ577102	EUDAMED	IVD General	Active
HISCL Probe Washing Solution	AQ202479	EUDAMED	Class A	Active

Related Companies

Authorised Representatives

Sysmex Europe SE DE

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Notified Bodies

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Authorities

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FDA Establishments (1)

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

Sysmex Corp. US