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Hemosonics LLC

United States·US-MF-000034476

Last updated May 30, 2026

Information

Device	Model / Reference	Registries	Class	Status
QStat Cartridge	QStat Cartridge KIT (Box of 10)	FDA UDI	N/A	Active
Quantra QPlus System	KT-0034	FDA UDI	Class II	Unknown
Quantra QPlus System	KT-0025	FDA UDI	Class II	Active
Quantra QPlus System	KT-0023	FDA UDI	Class II	Active
Quantra QPlus System	HS-002	FDA UDI	Class II	Active
Quantra QPlus System	KT-0004	FDA UDI	Class II	Active
Quantra QPlus System	KT-0033	FDA UDI	Class II	Unknown
Qstat Control Level 2	QStat Control Level 2 Kit (Box of 4)	FDA UDI	N/A	Active
Qstat Control Level 1	QStat Control Level 1 Kit (Box of 4)	FDA UDI	N/A	Active
Quantra QPlus System	KT-0039	FDA UDI	Class II	Active
Printer Kit WW	KT-0015	EUDAMED	Class A	Active
Quantra QStat Cartridge	K251404	FDA 510(k)	Class II	Active
Quantra QPlus System	K201513	FDA 510(k)	Class II	Active
QStat Cartridge	K213917	FDA 510(k)	Class II	Active
QStat Cartridge	K240045	FDA 510(k)	Class II	Active
Quantra QPlus System	K223433	FDA 510(k)	Class II	Active
Desktop Remote Viewer	KT-0016	EUDAMED	Class A	Active
Cleaning Cartridge	KT-0012	EUDAMEDFDA UDI	Class A	Active
Quantra Hemostasis Analyzer	HS-001	EUDAMEDFDA 510(k)	Class A	Active
Quantra Accessory Kit -Power Cord; Barcode Scanner EU	KT-0029	EUDAMED	Class A	Active

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Not available yet.