FDA Registration
Active
🇺🇸 United States
Medeologix LLC
Reg #: 3008791915
·
FEI: 3008791915
·
Expires 2026
Products
9
Proprietary Names
8
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Medeologix LLC
- Registration Number
- 3008791915
- FEI Number
- 3008791915
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2200 ZANKER RD STE F
- City
- San Jose
- State
- CA
- ZIP
- 95131
- Country
- US
Owner / Operator
- Firm Name
- Medeologix LLC
- Operator Number
- 10033936
- Address
- 2200 Zanker Rd, Unit F
- City
- San Jose
- State
- CA
- Postal Code
- 95131
- Country
- US
- Correspondent
- Shawn Davis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intraoral Pressure Gradient Device | OZR | Class 2 | Dental | No | 2023-11-01 |
| Polymer, Ear, Nose And Throat, Synthetic, Absorbable | NHB | Class 2 | Ear, Nose, Throat | No | 2026-03-03 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2026-04-08 |
| Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia | QKA | Class 2 | Gastroenterology, Urology | No | 2026-04-08 |
| Magnetic Surgical System | PNL | Class 2 | General, Plastic Surgery | No | 2018-08-06 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | Class 2 | Cardiovascular | No | 2016-01-29 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-04-15 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2018-10-30 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2018-10-30 |
Proprietary Names
iNAP One Sleep Therapy System
SeptAlign
Prodeon Urethral Sheath System
Urocross Expander System (Model Numbers ES2018 and ES3025)
Magnetic Surgical System
QuantaFlo
Pulse Biosciences
IRRAflow CNS System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)