FDA Registration
Active
🇺🇸 United States
GEREONICS, INC.
Reg #: 2025694
·
FEI: 2025694
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- GEREONICS, INC.
- Registration Number
- 2025694
- FEI Number
- 2025694
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 117 Sanctuary
- City
- Irvine
- State
- CA
- ZIP
- 92620
- Country
- US
Regulatory Submissions
- 510(k) Number
- K043009
Owner / Operator
- Firm Name
- GEREONICS, INC.
- Operator Number
- 2025694
- Address
- 117 Sanctuary, --
- City
- Irvine
- State
- CA
- Postal Code
- 92620
- Country
- US
- Correspondent
- MAZDAK - ROOEIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2026-02-19 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2026-02-19 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2007-08-20 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2007-08-20 |
Proprietary Names
BraiNet
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
GEREONICS BIOPOTENTIAL SKIN ELECTRODES
BriaNet
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device