FDA Registration
Active
🇦🇹 Austria
Baha Soundband
Reg #: 3012593436
·
FEI: 3012593436
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ING. GERHARD FILDAN GMBH
- Registration Number
- 3012593436
- FEI Number
- 3012593436
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ing. Gerhard Fildan Strasse 1
- City
- Ebenfurth Niederosterreich
- Country
- AT
Regulatory Submissions
- 510(k) Number
- K250215
Owner / Operator
- Firm Name
- Ing. Gerhard Fildan GmbH
- Operator Number
- 10092154
- Address
- Ing. Gerhard Fildan Strasse 1
- City
- Ebenfurth
- State
- Niederosterreich
- Postal Code
- 2490
- Country
- AT
- Correspondent
- Gerhard Fildan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2025-06-03 |
Proprietary Names
Baha Soundband
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)