Contract manufacturerBayer Medical Care Inc. (Pittsburgh, PA)PennsylvaniaCardiovascularClass II
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 code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Class II | Cardiovascular | Contract manufacturing | Dec 9, 2024 |
| IZQ | Injector, Contrast Medium, Automatic | Class II | Cardiovascular | Contract manufacturing | Dec 9, 2024 |