Haemonetics S.A.
CH-MF-000034549 · Switzerland · Signy-Centre
Haemonetics S.A. is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 27 |
|---|---|
| Class IIa | 5 |
Most frequent device types declared: CONC PLT & PLS SET W/FILTER, PLT & PLS SET W/FILTER, PLT & PLS Set Double Dose, PLT & PLS Set Single Dose, PLT&RBC Set w/PLT&RBC Filter.
Among these devices, 32 are declared sterile.
Authorised representative in the Union: Haemonetics Italia s.r.l.
Devices declared under this manufacturer
- CONC PLT & PLS SET W/FILTER
- CONNECTOR, SPIKE/MALE LL
- PLS 2-Bags Closed Set, HS Bowl
- PLS 3-BAG FFP SET, HS BWL
- PLS 3-BAGS CLOSED SET, HS BOWL
- PLS 3-Bags Closed Sets, BMB
- PLS BUNDLED SET W/AIR BAG
- PLS BUNDLED SET W/SALINE LINE
- PLS BUNDLED SET W/VAC
- PLS Bundled Sets w/Vac
- PLT & PLS SET DOUBLE DOSE
- PLT & PLS SET W/FILTER
Showing 12 of 32 declared devices.
Catalogue references include 00782-CC, 00792-CC, 0623E-00, 623HS-CC, 949FF-E-CC, 996E2-00.
European nomenclature codes declared: B030101, B030104.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 32 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 32 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 6.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | HAEMONETICS S.A. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2016-09-14 |
Licence types: System (1).
Licensed under: TEG 6S.
North American profile: Canada only. Haemonetics S.A. holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 071750 0032 | restricted | 2030-10-08 |