Contract manufacturerSPECTRA MEDICAL DEVICES, LLC (Wilmington, MA)MassachusettsGeneral and plastic surgeryOphthalmicClass I
SPECTRA MEDICAL DEVICES, LLC
Contract manufacturer · Wilmington, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1224960 (openFDA record; or search FDA's registration database)
- FEI number
- 3000204727
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- SPECTRA MEDICAL DEVICES, LLC (FDA owner/operator no. 9012618)
- Registered address
- 299 Ballardvale St Ste 1, Wilmington, MA 01887
- Contract listings
- 2 device listings, 2 product codes, first listed Sep 5, 2023
- 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 |
|---|---|---|---|---|---|
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract manufacturing | Sep 5, 2023 |
| HMX | Cannula, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Sep 5, 2023 |