Contract manufacturerContract sterilizerPrimo Medical Group, INC (Stoughton, MA)MassachusettsCardiovascularDentalEar, nose and throatGastroenterology and urologyGeneral and plastic surgeryGeneral hospitalNeurologyOrthopedicObstetrics and gynecologyClass IIClass IClass III
Primo Medical Group, INC
Contract manufacturer and sterilizer · Stoughton, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1222928 (openFDA record; or search FDA's registration database)
- FEI number
- 1000120613
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer; Contract sterilizer
- Owner or operator
- Primo Medical Group, Inc (FDA owner/operator no. 9004401)
- Registered address
- 75 Mill St, Stoughton, MA 02072
- Contract listings
- 65 device listings, 59 product codes, first listed Aug 14, 1992
- 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 |
|---|---|---|---|---|---|
| DWE | Tubing, Pump, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Jun 11, 2013 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Jun 11, 2013 |
| EJX | Anchor, Preformed | Class I | Dental | Contract manufacturing | Dec 17, 2013 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Class II | Ear, nose and throat | Contract manufacturing | Aug 2, 2018 |
| FDA | Enteroscope And Accessories | Class II | Gastroenterology and urology | Contract manufacturing | Nov 20, 2025 |
| 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 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Mar 21, 2014 |
| 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 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract manufacturing | Aug 19, 2024 |
| FZT | Cutter, Surgical | Class I | General and plastic surgery | Contract manufacturing | Aug 19, 2024 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Nov 18, 2013 |
| GAG | Stapler, Surgical | Class II | General hospital | Contract manufacturing | Sep 20, 2017 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Jan 30, 2013 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class I | General and plastic surgery | Contract manufacturing | Aug 14, 1992 |
| GDF | Guide, Needle, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| GDW | Staple, Implantable | Class II | General and plastic surgery | Contract manufacturing | Sep 20, 2017 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Sep 20, 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 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Aug 22, 2019 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Sep 23, 2023 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Nov 18, 2013 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Sep 23, 2023 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Aug 30, 2023 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Nov 18, 2013 |
| HWQ | Passer | Class I | Orthopedic | Contract manufacturing | Aug 19, 2024 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Nov 18, 2013 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Aug 19, 2024 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Nov 18, 2013 |
| JDR | Staple, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jun 23, 2025 |
| JOK | Scissors, Medical, Disposable | Class I | General hospital | Contract manufacturing | Aug 14, 1992 |
| KDC | Instrument, Surgical, Disposable | Class I | General and plastic surgery | Contract manufacturing | Aug 19, 2024 |
| KMJ | Lubricant, Patient | Class I | General hospital | Contract manufacturing | Jan 30, 2013 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | Class II | Orthopedic | Contract manufacturing | Jan 30, 2013 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | Class II | General hospital | Contract manufacturing | Sep 2, 2025 |
| LTI | Implant, Intragastric For Morbid Obesity | Class III | Gastroenterology and urology | Contract manufacturing | Nov 6, 2015 |
| LTI | Implant, Intragastric For Morbid Obesity | Class III | Gastroenterology and urology | Contract sterilization | Nov 6, 2015 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Nov 20, 2015 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Nov 27, 2023 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| MNB | Device, Thermal Ablation, Endometrial | Class III | Obstetrics and gynecology | Contract manufacturing | Apr 27, 2020 |
| MUU | System, Suction, Lipoplasty | Class II | General and plastic surgery | Contract manufacturing | May 8, 2013 |
| MZY | Graft, Vascular, Stainless Steel Tunneler | Class II | Cardiovascular | Contract manufacturing | Feb 10, 2016 |
| NBH | Accessories, Arthroscopic | Class I | Orthopedic | Contract manufacturing | Aug 19, 2024 |
| NDP | Accessories, Implant, Dental, Endosseous | Class I | Dental | Contract manufacturing | Dec 17, 2013 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | Contract manufacturing | Jan 30, 2013 |
| NJD | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 6, 2020 |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class II | Dental | Contract manufacturing | Jan 30, 2013 |
| OQL | Mesh, Surgical, Deployment Balloon | Class II | General and plastic surgery | Contract manufacturing | Jan 30, 2013 |
| PIH | Urethral Insert With Pump For Bladder Drainage | Class II | Gastroenterology and urology | Contract manufacturing | Sep 7, 2018 |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class II | Gastroenterology and urology | Contract manufacturing | May 17, 2021 |
| QPB | System, Suction, Lipoplasty For Removal | Class II | General and plastic surgery | Contract manufacturing | Mar 26, 2013 |