Contract manufacturerCEA Medical Manufacturing, Inc. (Colorado Springs, CO)ColoradoCardiovascularGeneral and plastic surgeryGastroenterology and urologyNeurologyPhysical medicineRadiologyClass IIClass IUnclassifiedClass III
CEA Medical Manufacturing, Inc.
Contract manufacturer · Colorado Springs, CO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1721983 (openFDA record; or search FDA's registration database)
- FEI number
- 1000064530
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer
- Owner or operator
- Nissha Medical Technologies (FDA owner/operator no. 9002200)
- Registered address
- 1755 Merchants Ct, Colorado Springs, CO 80916
- Contract listings
- 34 device listings, 21 product codes, first listed Jul 7, 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 |
|---|---|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Class II | Cardiovascular | Contract manufacturing | Feb 25, 2013 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Sep 11, 2017 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Dec 12, 2012 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Dec 4, 2009 |
| GWM | Device, Monitoring, Intracranial Pressure | Class II | Neurology | Contract manufacturing | Dec 18, 2012 |
| GXD | Generator, Lesion, Radiofrequency | Class II | Neurology | Contract manufacturing | Oct 12, 2020 |
| GXI | Probe, Radiofrequency Lesion | Class II | Neurology | Contract manufacturing | Mar 18, 2014 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 12, 2012 |
| HCA | Catheter, Ventricular | Class II | Neurology | Contract manufacturing | Jan 5, 2022 |
| IKD | Cable, Electrode | Class II | Physical medicine | Contract manufacturing | Jul 7, 1992 |
| IWJ | System, Applicator, Radionuclide, Manual | Class I | Radiology | Contract manufacturing | Sep 24, 2024 |
| JXG | Shunt, Central Nervous System And Components | Class II | Neurology | Contract manufacturing | Dec 12, 2012 |
| KNW | Instrument, Biopsy | Class II | Gastroenterology and urology | Contract manufacturing | Jan 7, 2013 |
| LFL | Instrument, Ultrasonic Surgical | Unclassified | General and plastic surgery | Contract manufacturing | Dec 12, 2012 |
| LPB | Cardiac Ablation Percutaneous Catheter | Class III | Cardiovascular | Contract manufacturing | Feb 26, 2013 |
| NEY | System, Ablation, Microwave And Accessories | Class II | General and plastic surgery | Contract manufacturing | Dec 18, 2012 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Class III | Cardiovascular | Contract manufacturing | May 12, 2021 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class III | Cardiovascular | Contract manufacturing | Jun 10, 2021 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | Class II | General and plastic surgery | Contract manufacturing | Dec 12, 2012 |
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Class III | Cardiovascular | Contract manufacturing | Dec 20, 2023 |
| SIR | Integrated Operating Table-Electromechanical Surgical System | Class II | General and plastic surgery | Contract manufacturing | Aug 11, 2026 |