MedtechSourcebook

SIEMENS MEDICAL SOLUTIONS USA, INC.

Contract manufacturer · Hoffman Estates, IL

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1423253 (openFDA record; or search FDA's registration database)
FEI number
1000514697
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer; Remanufacturer
Owner or operator
SIEMENS MEDICAL SOLUTIONS USA, INC. (FDA owner/operator no. 9002915)
Registered address
2501 NORTH BARRINGTON RD., Hoffman Estates, IL 60192
Contract listings
2 device listings, 2 product codes, first listed Jun 29, 2026
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
MUEFull Field Digital, System, X-Ray, MammographicClass IIRadiologyContract manufacturingJun 29, 2026
OTEDigital Breast TomosynthesisClass IIIRadiologyContract manufacturingJul 7, 2026