FDA Registration
Active
🇵🇱 Poland
FIDELTRONIK POLAND SP. Z O.O.
Reg #: 3011766844
·
FEI: 3011766844
·
Expires 2026
Products
12
Proprietary Names
1
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- FIDELTRONIK POLAND SP. Z O.O.
- Registration Number
- 3011766844
- FEI Number
- 3011766844
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Beniowskiego St. 1
- City
- Sucha Beskidzka Malopolskie
- Country
- PL
Owner / Operator
- Firm Name
- Fideltronik Poland sp. z o.o.
- Operator Number
- 10095302
- Address
- Beniowskiego St. 1
- City
- Sucha Beskidzka
- State
- PL-NOTA
- Postal Code
- 32-020
- Country
- PL
US Agent
- Business Name
- Willow Glen Consultancy LLC
- Contact Name
- Wen Wang
- Address
- 8880 Rio San Diego Dr., #800
- City
- San Diego
- State
- CA
- ZIP
- 92108
- Country
- US
- [email protected]
- Phone
- 619 8690249
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2026-02-22 |
| Electrode, Cortical | GYC | Class 2 | Neurology | No | 2026-02-22 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2026-02-22 |
| Stimulator, Mechanical, Evoked Response | GZP | Class 2 | Neurology | No | 2026-02-22 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2026-02-22 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2026-02-22 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2026-02-22 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2026-02-22 |
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2026-02-22 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2026-02-22 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2026-02-22 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2026-02-22 |
Proprietary Names
Natus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)