FDA Registration
Active
🇸🇪 Sweden
Hearing aid, bone conduction, implanted
Reg #: 3005216725
·
FEI: 3005216725
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CENOVA AB
- Registration Number
- 3005216725
- FEI Number
- 3005216725
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4, FLORETTGATAN
- City
- MJOLBY Ostergotland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K203807
Owner / Operator
- Firm Name
- CENOVA AB
- Operator Number
- 9043892
- Address
- 4, FLORETTGATAN, --
- City
- MJOLBY
- State
- SE-NOTA
- Postal Code
- 595 43
- Country
- SE
- Correspondent
- Jeanette - Erbay
US Agent
- Business Name
- Obelix Consulting
- Contact Name
- Elisa Maldonado-Holmertz
- Address
- 806 Jefferson St
- City
- Bastrop
- State
- TX
- ZIP
- 78602
- Country
- US
- [email protected]
- Phone
- 512 4316069
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Bone Conduction, Implanted | MAH | Class 2 | Ear, Nose, Throat | No | 2021-12-08 |
Proprietary Names
Hearing aid, bone conduction, implanted
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)