Contract manufacturerCOGMEDIX (West Boylston, MA)MassachusettsGeneral and plastic surgeryNeurologyPhysical medicineClinical chemistryRadiologyClass IIClass IClass III
COGMEDIX
Contract manufacturer · West Boylston, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3007712511 (openFDA record; or search FDA's registration database)
- FEI number
- 3007712511
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Cogmedix, Inc. (FDA owner/operator no. 10027034)
- Registered address
- 127 Hartwell St., West Boylston, MA 01583
- Contract listings
- 22 device listings, 12 product codes, first listed Apr 27, 2009
- 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 |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Dec 14, 2020 |
| GEX | Powered Laser Surgical Instrument | Class II | General and plastic surgery | Contract manufacturing | Mar 7, 2013 |
| HCC | Device, Biofeedback | Class II | Neurology | Contract manufacturing | Apr 7, 2011 |
| IQI | Orthosis, Limb Brace | Class I | Physical medicine | Contract manufacturing | Jan 2, 2014 |
| IRT | Pad, Heating, Powered | Class II | Physical medicine | Contract manufacturing | Feb 15, 2024 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Class I | Clinical chemistry | Contract manufacturing | Aug 23, 2024 |
| NUV | Massager, Vacuum, Light Induced Heating | Class II | General and plastic surgery | Contract manufacturing | Apr 27, 2009 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | Class II | General and plastic surgery | Contract manufacturing | Sep 19, 2017 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | Class II | General and plastic surgery | Contract manufacturing | Dec 14, 2020 |
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | Class II | General and plastic surgery | Contract manufacturing | Sep 19, 2017 |
| QAI | Powered Microneedle Device | Class II | General and plastic surgery | Contract manufacturing | Apr 22, 2019 |
| QNK | Optoacoustic Imaging System | Class III | Radiology | Contract manufacturing | Feb 26, 2022 |