Contract manufacturerZOE MEDICAL, INC. (Topsfield, MA)MassachusettsCardiovascularClass II
ZOE MEDICAL, INC.
Contract manufacturer ยท Topsfield, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003294644 (openFDA record; or search FDA's registration database)
- FEI number
- 3003294644
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Zoe Medical, Inc (FDA owner/operator no. 9041242)
- Registered address
- 460 BOSTON ST., Topsfield, MA 01983
- Contract listings
- 2 device listings, 2 product codes, first listed Dec 12, 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 |
|---|---|---|---|---|---|
| DPS | Electrocardiograph | Class II | Cardiovascular | Contract manufacturing | Dec 12, 2024 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Class II | Cardiovascular | Contract manufacturing | Dec 12, 2024 |