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Sign in to claim this brandHaemonetics 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
- Website
- haemonetics.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Julie Ryan
- EUDAMED SRN
- CH-MF-000034549
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Plt & Pls Set W/Filter | 997CF-E-CC | EUDAMED | Class IIb | Active |
| PLS 2-Bags Closed Set, HS Bowl | 622HS-00 | EUDAMED | Class IIb | Active |
| Plt & Pls Set Single Dose | 0996E-00 | EUDAMED | Class IIb | Active |
| PLS Bundled Sets w/Saline Line | 00783-00 | EUDAMED | Class IIb | Active |
| Plt & Rbc Set W/Plt & Rbc Filter | 949FF-E-CC | EUDAMED | Class IIb | Active |
| PLS 3-Bags Closed Set, HS Bowl | 623HS-00 | EUDAMED | Class IIb | Active |
| Pls 3-Bag Ffp Set, Hs Bwl | 623HS-NX-CC | EUDAMED | Class IIb | Active |
| Pls Bundled Set W/Saline Line | 00783-CC | EUDAMED | Class IIb | Active |
| Connector, Spike/Male Ll | 00621-00 | EUDAMED | Class IIa | Active |
| Plt & Pls Set Single Dose | 0996E-CN | EUDAMED | Class IIb | Active |
| Pls Harness Set W/Drip | 0620E-CC | EUDAMED | Class IIa | Active |
| PLS 3-Bags Closed Sets, BMB | 0623E-00 | EUDAMED | Class IIb | Active |
| PLS Bundled Sets w/Vac | 00792-00 | EUDAMED | Class IIb | Active |
| Plt&Rbc Set W/Plt&Rbc Filter | 949FF-E | EUDAMED | Class IIb | Active |
| PLS Bundled Set w/Air Bag | 00782-00 | EUDAMED | Class IIb | Active |
| Pls 3-Bag Ffp Set, Hs Bwl | 623HS-NX | EUDAMED | Class IIb | Active |
| Plt & Pls Set Double Dose | 996E2-00 | EUDAMED | Class IIb | Active |
| Pls 3-Bags Closed Set, Hs Bowl | 623HS-CC | EUDAMED | Class IIb | Active |
| Pls Bundled Set W/Air Bag | 00782-CC | EUDAMED | Class IIb | Active |
| Plt & Pls Set Double Dose | 996E2-CN | EUDAMED | Class IIb | Active |
| Conc Plt & Pls Set W/Filter | 999F-E-CC | EUDAMED | Class IIb | Active |
| Plt & Pls Set W/Filter | 997CF-E | EUDAMED | Class IIb | Active |
| Pls Harness Set | 00620-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Plasma Set, HS Bowl | 782HS-P-SL | EUDAMED | Class IIb | Active |
| Plasma Set w/Filter, BMB | 0792P-SL | EUDAMED | Class IIb | Active |
| Pls Harness Set | 00620‐CC | EUDAMEDFDA UDI | Class IIa | Active |
| Plt & Plasma Set W/Filters | 999FF-P-SL | EUDAMED | Class IIb | Active |
| Plt & Pls Set W/Filter | 997CF-E-CN | EUDAMED | Class IIb | Active |
| Pls Bundled Set W/Vac | 00792-CC | EUDAMED | Class IIb | Active |
| Conc Plt & Pls Set W/Filter | 999F-E | EUDAMED | Class IIb | Active |
| Plt&Pls Set W/Filt & Bact.samp | 997CF-E-BA | EUDAMED | Class IIb | Active |
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