MedtechSourcebook

Bayer Medical Care Inc.

Contract manufacturer · Pittsburgh, PA

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

FDA registration
3004056159 (openFDA record; or search FDA's registration database)
FEI number
3004056159
Registered for
FDA registration year 2026
Establishment types
Manufacturer for export only; Manufacturer; Contract manufacturer; Remanufacturer
Owner or operator
Bayer Medical Care Inc. (FDA owner/operator no. 2520313)
Registered address
625 Alpha Dr, Pittsburgh, PA 15238
Contract listings
2 device listings, 2 product codes, first listed Dec 9, 2024
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
DXTInjector And Syringe, AngiographicClass IICardiovascularContract manufacturingDec 9, 2024
IZQInjector, Contrast Medium, AutomaticClass IICardiovascularContract manufacturingDec 9, 2024