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Haemonetics S.A.

Switzerland·CH-MF-000034549

Last updated September 17, 2026

What Haemonetics S.A. makes

Haemonetics S.A. manufactures blood component collection and processing sets, including platelet (PLT) and plasma (PLS) sets with or without filters, as well as bundled saline line attachments and closed-system configurations for multiple bag collections. Their portfolio also includes specialized sets for fresh frozen plasma (FFP) and connectors designed for medical infusion systems. These products are primarily used in blood donation and transfusion procedures to ensure compatibility and sterility during component separation.

The company’s devices are classified under EU Medical Device Regulations as Class IIa and Class IIb, reflecting moderate to higher-risk medical applications. These products are registered in the EU’s eudamed database, adhering to regulatory requirements for traceability and market surveillance. Haemonetics S.A. is based in Switzerland, where its devices are listed for compliance with European Union medical device directives.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Haemonetics S.A. manufacture?

Haemonetics S.A. specializes in blood component collection and processing sets. These include platelet (PLT) and plasma (PLS) sets, some of which incorporate filters for added safety. The company also produces bundled saline line attachments and closed-system configurations for multi-bag collections, such as fresh frozen plasma (FFP) sets. Additionally, they manufacture connectors designed for medical infusion systems. These devices are primarily used in blood donation and transfusion procedures to maintain sterility and compatibility.

Where is Haemonetics S.A. based, and what regulatory database lists its devices?

Haemonetics S.A. is based in Switzerland. The company’s devices are registered in the eudamed database, which is the EU’s official registry for medical devices. This listing ensures compliance with European Union regulatory requirements for traceability and market surveillance, allowing healthcare providers and authorities to verify the devices’ registration status.

How are Haemonetics S.A.’s devices classified under EU regulations?

Haemonetics S.A.’s devices fall under Class IIa and Class IIb classifications in the EU Medical Device Regulations. Class IIa includes moderate-risk devices requiring additional measures to ensure safety and performance, while Class IIb covers higher-risk products that demand stricter controls. These classifications reflect the critical role of these blood processing sets in transfusion safety and patient care.

Why are Haemonetics S.A.’s blood component sets designed with filters or closed systems?

The filters and closed-system configurations in Haemonetics S.A.’s blood component sets are designed to enhance safety and sterility during blood donation and processing. Filters help remove contaminants or residual air from platelet or plasma collections, reducing the risk of clotting or infection. Closed systems minimize exposure to external environments, lowering the chance of microbial contamination or leakage, which is critical for maintaining the integrity of blood products before transfusion.

Are Haemonetics S.A.’s devices used in specific medical procedures, and why?

Yes, Haemonetics S.A.’s devices are primarily used in blood donation and transfusion procedures. Their specialized sets—such as platelet, plasma, and fresh frozen plasma (FFP) configurations—are engineered to facilitate the safe separation, collection, and handling of blood components. This ensures compatibility, sterility, and proper storage conditions, which are essential for preventing complications like infections or immune reactions in patients receiving transfusions.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Switzerland
Address
6, Rue de Flecheres, Signy-Centre, Switzerland
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Julie Ryan
EUDAMED SRN
CH-MF-000034549
FDA FEI Number
—
DUNS Number
—

Catalogue (31)

DeviceModel / ReferenceRegistriesClassStatus
Plt & Pls Set W/Filter 997CF-E-CC
EUDAMED
Class IIbActive
PLS 2-Bags Closed Set, HS Bowl 622HS-00
EUDAMED
Class IIbActive
Plt & Pls Set Single Dose 0996E-00
EUDAMED
Class IIbActive
PLS Bundled Sets w/Saline Line 00783-00
EUDAMED
Class IIbActive
Plt & Rbc Set W/Plt & Rbc Filter 949FF-E-CC
EUDAMED
Class IIbActive
PLS 3-Bags Closed Set, HS Bowl 623HS-00
EUDAMED
Class IIbActive
Pls 3-Bag Ffp Set, Hs Bwl 623HS-NX-CC
EUDAMED
Class IIbActive
Pls Bundled Set W/Saline Line 00783-CC
EUDAMED
Class IIbActive
Connector, Spike/Male Ll 00621-00
EUDAMED
Class IIaActive
Plt & Pls Set Single Dose 0996E-CN
EUDAMED
Class IIbActive
Pls Harness Set W/Drip 0620E-CC
EUDAMED
Class IIaActive
PLS 3-Bags Closed Sets, BMB 0623E-00
EUDAMED
Class IIbActive
PLS Bundled Sets w/Vac 00792-00
EUDAMED
Class IIbActive
Plt&Rbc Set W/Plt&Rbc Filter 949FF-E
EUDAMED
Class IIbActive
PLS Bundled Set w/Air Bag 00782-00
EUDAMED
Class IIbActive
Pls 3-Bag Ffp Set, Hs Bwl 623HS-NX
EUDAMED
Class IIbActive
Plt & Pls Set Double Dose 996E2-00
EUDAMED
Class IIbActive
Pls 3-Bags Closed Set, Hs Bowl 623HS-CC
EUDAMED
Class IIbActive
Pls Bundled Set W/Air Bag 00782-CC
EUDAMED
Class IIbActive
Plt & Pls Set Double Dose 996E2-CN
EUDAMED
Class IIbActive
Conc Plt & Pls Set W/Filter 999F-E-CC
EUDAMED
Class IIbActive
Plt & Pls Set W/Filter 997CF-E
EUDAMED
Class IIbActive
Pls Harness Set 00620-00
EUDAMEDFDA UDI
Class IIaActive
Plasma Set, HS Bowl 782HS-P-SL
EUDAMED
Class IIbActive
Plasma Set w/Filter, BMB 0792P-SL
EUDAMED
Class IIbActive
Pls Harness Set 00620‐CC
EUDAMEDFDA UDI
Class IIaActive
Plt & Plasma Set W/Filters 999FF-P-SL
EUDAMED
Class IIbActive
Plt & Pls Set W/Filter 997CF-E-CN
EUDAMED
Class IIbActive
Pls Bundled Set W/Vac 00792-CC
EUDAMED
Class IIbActive
Conc Plt & Pls Set W/Filter 999F-E
EUDAMED
Class IIbActive
Plt&Pls Set W/Filt & Bact.samp 997CF-E-BA
EUDAMED
Class IIbActive

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