FDA Registration
Active
🇺🇸 United States
CEA Medical Manufacturing, Inc.
Reg #: 1721983
·
FEI: 1000064530
·
Expires 2026
Products
20
Proprietary Names
26
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- CEA Medical Manufacturing, Inc.
- Registration Number
- 1721983
- FEI Number
- 1000064530
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1755 Merchants Ct
- City
- Colorado Springs
- State
- CO
- ZIP
- 80916
- Country
- US
Owner / Operator
- Firm Name
- Nissha Medical Technologies
- Operator Number
- 9002200
- Address
- 400 Exchange Street, --
- City
- Buffalo
- State
- NY
- Postal Code
- 14204
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2013-02-26 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2023-12-20 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2012-12-12 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2013-02-25 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-02-07 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 1992-07-07 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2012-12-12 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2024-09-24 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2021-04-16 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2021-05-12 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2017-09-11 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2012-12-12 |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | Class 2 | General, Plastic Surgery | No | 2012-12-12 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2012-12-12 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2012-12-18 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2013-01-07 |
| Catheter, Ventricular | HCA | Class 2 | Neurology | No | 2022-01-05 |
| System, Ablation, Microwave And Accessories | NEY | Class 2 | General, Plastic Surgery | No | 2012-12-18 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2020-10-12 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2021-06-10 |
Proprietary Names
RF Catheter Cable
STRATA II VALVE
Atakr to ECG Cable, conductors-sterile, shrouded pin
CAIMAN
STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING (Component ONLY)
TransDiscal* Y-Connecting Cable
lntellaTip MiFi Reference Cable Non-Sterile
CARDIOBLATE TISSUE DISSECTOR
CARDIOBLATE LP
CABLE EGM
CARDIOBLATE DISP ELEC ADPTR
CARDIOBLATE BP
CARDIOBLATE GEMINI
ECG Cable
Nitron Remote
Exacta Pole Clamp
Mammotome Keypad and MR Lockbox
Exacta External Drainage and Monitoring System
Kimberly-Clark Radiofrequency Cables
MicroThermX Microwave Ablation System (MTX-180)
COOLIEF* COOLED RADIOFREQUENCY CONNECTOR CABLE
CARDIOBLATE GEMINI OUS
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
4-Lead EGM Cable
990004 Catheter Interface Cable
EX Holster
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only