Contract manufacturerOnCore Manufacturing (Westborough, MA)MassachusettsCardiovascularPhysical medicineClass IIClass I
OnCore Manufacturing
Contract manufacturer · Westborough, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003695829 (openFDA record; or search FDA's registration database)
- FEI number
- 3003695829
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Remanufacturer
- Owner or operator
- OnCore Manufacturing LLC (FDA owner/operator no. 10050743)
- Registered address
- 125 Fisher Street, Westborough, MA 01581
- Contract listings
- 7 device listings, 5 product codes, first listed Jun 26, 2019
- 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 |
|---|---|---|---|---|---|
| DSB | Plethysmograph, Impedance | Class II | Cardiovascular | Contract manufacturing | Jan 28, 2024 |
| MNW | Analyzer, Body Composition | Class II | Cardiovascular | Contract manufacturing | Jan 28, 2024 |
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | Class II | Cardiovascular | Contract manufacturing | Jan 28, 2024 |
| OIZ | Foot Examination Tool For Inflammatory Changes | Class I | Physical medicine | Contract manufacturing | Jun 26, 2019 |
| QJB | Adjunct Monitor, Protein Calorie Malnutrition | Class II | Cardiovascular | Contract manufacturing | Jan 28, 2024 |