Contract manufacturerPrimo Medical Group, Inc (W Bridgewater, MA)MassachusettsAnesthesiologyGeneral hospitalCardiovascularEar, nose and throatGastroenterology and urologyPathologyGeneral and plastic surgeryNeurologyObstetrics and gynecologyOphthalmicPhysical medicineClinical chemistryDentalClass IClass IIClass III
Primo Medical Group, Inc
Contract manufacturer · W Bridgewater, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009420598 (openFDA record; or search FDA's registration database)
- FEI number
- 3009420598
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Primo Medical Group, Inc (FDA owner/operator no. 9004401)
- Registered address
- 375 West St, W Bridgewater, MA 02379
- Contract listings
- 59 device listings, 51 product codes, first listed Jan 30, 2013
- 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 |
|---|---|---|---|---|---|
| CAL | Laryngoscope, Non-Rigid | Class I | Anesthesiology | Contract manufacturing | Dec 11, 2017 |
| CBD | Bottle, Collection, Breathing System (Calibrated) | Class II | General hospital | Contract manufacturing | Dec 8, 2020 |
| CCW | Laryngoscope, Rigid | Class I | Anesthesiology | Contract manufacturing | Dec 11, 2017 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Jan 24, 2025 |
| DXF | Catheter, Septostomy | Class II | Cardiovascular | Contract manufacturing | Jun 9, 2026 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Class II | Ear, nose and throat | Contract manufacturing | Dec 11, 2017 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, nose and throat | Contract manufacturing | Dec 11, 2017 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Class II | Ear, nose and throat | Contract manufacturing | Aug 2, 2018 |
| EZO | Urethrotome | Class II | Gastroenterology and urology | Contract manufacturing | Nov 30, 2017 |
| FAS | Electrode, Electrosurgical, Active, Urological | Class II | Gastroenterology and urology | Contract manufacturing | Nov 30, 2017 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology and urology | Contract manufacturing | Jan 30, 2013 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract manufacturing | Jan 30, 2013 |
| FEO | Lithotriptor, Ultrasonic | Class II | Gastroenterology and urology | Contract manufacturing | Nov 30, 2017 |
| FMH | Container, Specimen, Sterile | Class I | Pathology | Contract manufacturing | Sep 7, 2018 |
| FST | Light, Surgical, Fiberoptic | Class II | General and plastic surgery | Contract manufacturing | Sep 23, 2019 |
| FTL | Mesh, Surgical, Polymeric | Class II | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Apr 23, 2017 |
| GAZ | Tubing, Noninvasive | Class II | General hospital | Contract manufacturing | Nov 30, 2017 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Jan 30, 2013 |
| GDG | Hook, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Oct 13, 2017 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Apr 21, 2017 |
| GWG | Endoscope, Neurological | Class II | Neurology | Contract manufacturing | Dec 11, 2017 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | Class II | Neurology | Contract manufacturing | Oct 13, 2017 |
| GZX | Instrument, Microsurgical | Class I | Neurology | Contract manufacturing | Dec 11, 2017 |
| HAO | Instrument, Surgical, Non-Powered | Class I | Neurology | Contract manufacturing | Oct 13, 2017 |
| HBC | Motor, Drill, Electric | Class II | Neurology | Contract manufacturing | Aug 2, 2018 |
| HBI | Illuminator, Fiberoptic, Surgical Field | Class II | General and plastic surgery | Contract manufacturing | Sep 23, 2019 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract manufacturing | Dec 11, 2017 |
| HIH | Hysteroscope (And Accessories) | Class II | Obstetrics and gynecology | Contract manufacturing | Dec 11, 2017 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | Class II | Obstetrics and gynecology | Contract manufacturing | Nov 30, 2017 |
| HJC | Esthesiometer, Ocular | Class I | Ophthalmic | Contract manufacturing | May 11, 2023 |
| ITQ | Joint, Knee, External Brace | Class I | Physical medicine | Contract manufacturing | Aug 18, 2017 |
| JRR | Regulator, Temperature | Class I | Clinical chemistry | Contract manufacturing | Jun 7, 2019 |
| KGT | Drape, Adhesive, Aerosol | Class I | General and plastic surgery | Contract manufacturing | Aug 18, 2017 |
| KMJ | Lubricant, Patient | Class I | General hospital | Contract manufacturing | Jan 30, 2013 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Class II | Obstetrics and gynecology | Contract manufacturing | Dec 11, 2017 |
| KYZ | Syringe, Irrigating (Non Dental) | Class I | General hospital | Contract manufacturing | Apr 12, 2021 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class I | Clinical chemistry | Contract manufacturing | Apr 11, 2024 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract manufacturing | May 8, 2013 |
| NKM | Mitral Valve Repair Devices | Class III | Cardiovascular | Contract manufacturing | Jul 18, 2023 |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class II | Dental | Contract manufacturing | Jan 30, 2013 |
| NPT | Aortic Valve, Prosthesis, Percutaneously Delivered | Class III | Cardiovascular | Contract manufacturing | Sep 23, 2021 |
| NPU | Prosthesis, Mitral Valve, Percutaneously Delivered | Class III | Cardiovascular | Contract manufacturing | Sep 23, 2021 |
| NVT | Tubing And Tubing/Filter Fits | Class I | Obstetrics and gynecology | Contract manufacturing | Dec 11, 2017 |
| NZE | Hyperthermia Monitor | Class II | Cardiovascular | Contract manufacturing | Sep 15, 2017 |
| OCX | Endoscopic Irrigation/Suction System | Class II | Gastroenterology and urology | Contract manufacturing | Nov 30, 2017 |
| OJG | Neurological Tray | Class I | Neurology | Contract manufacturing | Feb 12, 2019 |
| OOE | Ophthalmic Femtosecond Laser | Class II | Ophthalmic | Contract manufacturing | Sep 5, 2018 |
| OQL | Mesh, Surgical, Deployment Balloon | Class II | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| QPB | System, Suction, Lipoplasty For Removal | Class II | General and plastic surgery | Contract manufacturing | Mar 26, 2013 |