Manufacturer

Haemonetics

Switzerland, United StatesLegal entities : Haemonetics Corporation, Haemonetics S.A.

Markets : France · Germany · Hungary · Ireland · Italy · United States

Approvals : EU – class I, IIa, IIb, A · United States (FDA) – 510(k) : 36 · class I, II · latest in 2025 · see on the FDA website

Public contracts won : Italy 10 · France 9

EU representative : Haemonetics Italia s.r.l (Italy)

regulatoryeurope@haemonetics.com

19 categories, 50 models including 49 on the market, 2 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Autotransfusion devices - other	B0499	Aspiration & Anticoagulation Line Aspiration / Anticoagulation Set Cell Saver Elite Processing Kit (125mL) Cell Saver Elite Processing Kits3 refs Cell Saver Step Down Adapter CS Elite Fastpack, 125mL, 150μ Res3 refs 7 others RBC Bag w/Twist Lock, 1000mL Reservoir, Hard-Shell, 150µ2 refs Reservoir, Soft Shell, 170μ Filter2 refs Sequestration Kit Vacuum Line, Filtered Waste Bag, 10L Y Set with Extension Line	I, IIa, IIb MDR	EUDAMED record Report an error
Apheresis plasma collection devices	B030101	0625Q-00 Plasma Bowl3 refs CONNECTOR, SPIKE/MALE LL HS PLS Bowl Persona Plasma Pooling Bottle Plasma Bottle3 refs PLS 2-Bags Closed Set, HS Bowl Plasma Collection Sets with HS bowl3 refs 6 others PLS 3-Bags Closed Sets, BMB Plasma Collection Sets with BMB bowl3 refs PLS 3-Product Bags Plasma Harness-out Sets2 refs PLS Bag Plasma Harness-out Sets3 refs PLS Bundled Set w/NaCL w/Vac Plasma Collection Sets with BMB bowl PLS Harness Set3 refs PLS HARNESS SET Plasma Harness Sets3 refs	IIa, IIb MDR	EUDAMED record Report an error
Apheresis multiple blood component collection devices	B030104	CONC PLT & PLS SET W/FILTER2 refs PLT & PLASMA SET W/FILTERS PLT & PLS SET DOUBLE DOSE2 refs PLT & PLS SET SINGLE DOSE2 refs PLT & PLS SET W/FILTER3 refs 1 other PLT & RBC SET W/PLT & RBC FILTER2 refs	IIb MDR	EUDAMED record Report an error
Apheresis collection devices - other	B030199	RBC De-Glycerol. / Cell Wash Set2 refs RBC De-Glycerol. Set 325mL BMB RBC Glycerolization Set	IIa, IIb MDR	EUDAMED record Report an error
Blood donation apheresis equipment	Z12170401	ACP 21593/42 MCS+ 90003 refs93/42 NexSys PCS	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	TEG 6s QC Level 1 TEG 6s QC Level 2	A IVDR	EUDAMED record Report an error
Apheresis therapy devices - other	B030299	TPE Set (125mL Latham) Therapeutic Plasma Exchange Sets3 refs	IIb MDR	EUDAMED record Report an error
Bed-side erythrocytes (RBC) leukoreduction filters (with or without infusion controller)	B02010101	RN Neonatal High Efficiency Leucocyte Removal Filter for Red Cells93/42	IIb 93/42	EUDAMED record Report an error
Bed-side leukoreduction filters - other	B02010199	RC High Efficiency Leucocyte Removal Filter with Attached Set for Blood Transfusion2 refs93/42	IIa 93/42	EUDAMED record Report an error
Blood bags and kits - other	B0199	ELX platelet Storage Bag93/42	IIb 93/42	EUDAMED record Report an error
Blood transfusion instruments - other	Z121799	BloodTrack	IIb MDR	EUDAMED record Report an error
Haemostasis reagents - other	W01030299	Antiplatelet Reagent	A IVDR	EUDAMED record Report an error
Laboratory leukoreduction filters - other	B02010299	High Efficiency Post-Process Filter System for Leucocyte Removal from Red Cells2 refs93/42	IIb 93/42	EUDAMED record Report an error
Laboratory platelets leukoreduction filters	B02010202	High Efficiency In-Process Filter System for Leucocyte Removal from Pooled Buffy Coat Platelets5 refs93/42	IIb 93/42	EUDAMED record Report an error
Massive transfusion therapy filters, with transfusion controller	B020201	BLOOD TRANSFUSION FILTER SET SQ40S3 refs	IIa MDR	EUDAMED record Report an error
Self-transfusion equipment	Z120104	Cell Saver Elite+3 refs	IIa MDR	EUDAMED record Report an error
Thrombelastographs	W0202029001	TEG 6s Hemostasis System	A IVDR	EUDAMED record Report an error
Whole blood, red blood cells or plasma transfer bags and kits	B010201	Cryoprecipitate Pooling Set93/42	IIb 93/42	EUDAMED record Report an error
Laboratory erythrocytes (RBC) leukoreduction filters No model still on the market	B02010201	High Efficiency Post-Process Filter System for Leucocyte Removal from Red Cells2 refs93/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error

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