Baxter Healthcare SA
CH-MF-000026124 · Switzerland · Glattpark (Opfikon)
Baxter Healthcare SA is registered in the European database on medical devices as a manufacturer, with 186 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 90 |
|---|---|
| Class IIa | 96 |
Most frequent device types declared: 955725.
Among these devices, 136 are declared sterile, 18 active, 1 with a measuring function.
Authorised representative in the Union: Baxter Deutschland GmbH.
Devices declared under this manufacturer
- Adaptacap
- EVO IQ
- FOLFUSOR
- FlexFlo
- INFUSOR
- INTERMATE
- Irrigation Solutions
- PCA Syringe Sets
- PCEA Syringe Sets
- Press-In-Bottle-Adapter
- RAPIDFILL
- STERILE WATER FOR IRRIG (PLASTIC BOTTLE)
Showing 12 of 186 declared devices.
Catalogue references include 2C2123K, AKB7127, BLCCB7117S, EHUB005UKI, EHUB008GRC, ESYR001GRC.
European nomenclature codes declared: V9099, A05010101, A0799, V0880, Z12030302, A03040199.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | Baxter Healthcare - Tel Aviv (IL) · FDA 3005004021 |
| Devices in EUDAMED | 186 |
| Country of registration | Switzerland |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 186 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 0.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BAXTER HEALTHCARE SA |
What it holds in Canada
| Licences on record | 32 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 24 |
| Class 3 devices | 4 |
| Class 4 devices | 4 |
| First licensed | 1998-12-07 |
Licence types: Device Family (10), Device Group Family (10), Device Group (5), Single Device (5).
Licensed under: COLLEAGUE VOLUMETRIC INFUSION PUMPS, EXACTA-MED EVA CONTAINER, FLOSEAL HEMOSTATIC MATRIX, INFUSOR SYSTEM, DUPLOJECT SYSTEM, DUPLOCATH.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 056740 0072 | issued | 2029-11-05 |
G10 056740 0071 | issued | 2029-09-02 |
G10 056740 0065 | issued | 2029-11-06 |
G10 056740 0057 | issued | 2029-05-07 |
G10 056740 0047 | issued | 2029-10-24 |
G10 056740 0037 | issued | 2029-03-21 |
G10 056740 0024 | issued | 2028-01-17 |