Contract manufacturerSPARTRONICS STRONGSVILLE, INC. (Strongsville, OH)OhioCardiovascularGeneral hospitalOphthalmicGeneral and plastic surgeryImmunologyNeurologyClass II
SPARTRONICS STRONGSVILLE, INC.
Contract manufacturer ยท Strongsville, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3003144120 (openFDA record; or search FDA's registration database)
- FEI number
- 3004099094
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Spartronics Strongsville Inc. (FDA owner/operator no. 9008727)
- Registered address
- 22740 Lunn Rd, Strongsville, OH 44149
- Contract listings
- 17 device listings, 13 product codes, first listed Nov 30, 2007
- 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 |
|---|---|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | Class II | Cardiovascular | Contract manufacturing | May 1, 2024 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | Contract manufacturing | Nov 29, 2016 |
| FRN | Pump, Infusion | Class II | General hospital | Contract manufacturing | Nov 30, 2007 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Class II | Ophthalmic | Contract manufacturing | Aug 15, 2017 |
| HKI | Camera, Ophthalmic, Ac-Powered | Class II | Ophthalmic | Contract manufacturing | Aug 15, 2017 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | Class II | General and plastic surgery | Contract manufacturing | Aug 22, 2025 |
| KPJ | Chamber, Oxygen, Topical, Extremity | Class II | General and plastic surgery | Contract manufacturing | Jun 10, 2025 |
| LGZ | Warmer, Thermal, Infusion Fluid | Class II | General hospital | Contract manufacturing | Nov 30, 2007 |
| NQI | System, Immunomagnetic, Circulating Cancer Cell, Enumeration | Class II | Immunology | Contract manufacturing | Mar 20, 2015 |
| NRY | Catheter, Thrombus Retriever | Class II | Cardiovascular | Contract manufacturing | Dec 3, 2024 |
| OBP | Transcranial Magnetic Stimulator | Class II | Neurology | Contract manufacturing | Dec 9, 2008 |
| ORZ | Eyelid Thermal Pulsation System | Class II | Ophthalmic | Contract manufacturing | Aug 15, 2017 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | Class II | Neurology | Contract manufacturing | Mar 17, 2025 |