FDA Registration
Active
🇺🇸 United States
QUALITEL CORPORATION
Reg #: 3024673
·
FEI: 3024673
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- QUALITEL CORPORATION
- Registration Number
- 3024673
- FEI Number
- 3024673
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11831 Beverly Park Road, Bldg A
- City
- Everett
- State
- WA
- ZIP
- 98204
- Country
- US
Owner / Operator
- Firm Name
- QUALITEL CORPORATION
- Operator Number
- 9000166
- Address
- 11831 Beverly Park Road, Bldg. A, --
- City
- Everett
- State
- WA
- Postal Code
- 98204
- Country
- US
- Correspondent
- Reese Hughey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2013-01-11 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2015-12-30 |
| Recorder, Magnetic Tape, Medical | DSH | Class 2 | Cardiovascular | No | 2023-12-26 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2021-01-26 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2015-12-28 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2006-10-25 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2018-08-10 |
Proprietary Names
Medtronic PS Medical Exacta Drainage System
Medtronic PS Medical Exacta Drainage System Pole Clamp
Sentio
Transducer, ultrasonic, diagnostic
MEDTRONIC STRATAVARIOUS
SHERLOCK TIP LOCATION
3040-MMG2
Sherlock 3CG+ Tip Confirmation System, K180560
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)