EU → US Device Access

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 IIa96
Class IIb90

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: DE-AR-000010308.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryBaxter Healthcare - Tel Aviv (IL) · FDA 3005004021
Devices in EUDAMED186
Country of registrationSwitzerland
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Notified body certificates

CertificateStatusExpiry
G10 056740 0072issued2029-11-05
G10 056740 0071issued2029-09-02
G10 056740 0065issued2029-11-06
G10 056740 0057issued2029-05-07
G10 056740 0047issued2029-10-24
G10 056740 0037issued2029-03-21
G10 056740 0024issued2028-01-17

Other manufacturers in Switzerland

All Switzerland manufacturers →