Contract manufacturerPRO-TECH Design & Mfg, Inc. (Santa Fe Springs, CA)CaliforniaGastroenterology and urologyNeurologyObstetrics and gynecologyPhysical medicineOrthopedicGeneral and plastic surgeryClass IIClass IClass III
PRO-TECH Design & Mfg, Inc.
Contract manufacturer ยท Santa Fe Springs, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3013023969 (openFDA record; or search FDA's registration database)
- FEI number
- 3013023969
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- PRO-TECH Design & Mfg, Inc. (FDA owner/operator no. 9048910)
- Registered address
- 13719 Borate St, Santa Fe Springs, CA 90670
- Contract listings
- 10 device listings, 12 product codes, first listed Apr 25, 2016
- 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 |
|---|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Jul 24, 2017 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Class II | Neurology | Contract manufacturing | Apr 14, 2021 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Class II | Neurology | Contract manufacturing | Apr 14, 2021 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract manufacturing | Jul 24, 2017 |
| IQG | Adaptor, Holder, Syringe | Class I | Physical medicine | Contract manufacturing | Jun 28, 2016 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | Class II | Orthopedic | Contract manufacturing | Jan 27, 2022 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Class III | Neurology | Contract manufacturing | Mar 12, 2018 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| OAG | Garment, Storage, Peritoneal Dialysis Catheter | Class I | Physical medicine | Contract manufacturing | Apr 25, 2016 |
| PJS | Stimulator, Electrical, Implanted, For Essential Tremor | Class III | Neurology | Contract manufacturing | Dec 13, 2023 |
| QUQ | Knife, Intraocular Pressure Lowering | Class II | General and plastic surgery | Contract manufacturing | Jul 8, 2024 |