FDA Registration
Active
🇸🇪 Sweden
COCHLEAR BONE ANCHORED SOLUTIONS AB
Reg #: 9616024
·
FEI: 3003222064
·
Expires 2026
Products
8
Proprietary Names
36
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- COCHLEAR BONE ANCHORED SOLUTIONS AB
- Registration Number
- 9616024
- FEI Number
- 3003222064
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Konstruktionsvagen 14
- City
- Molnlycke Vastra Gotaland
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K231604
Owner / Operator
- Firm Name
- COCHLEAR AMERICAS
- Operator Number
- 9076254
- Address
- 10350 Park Meadows Drive
- City
- Lone Tree
- State
- CO
- Postal Code
- 80124
- Country
- US
US Agent
- Business Name
- Cochlear Americas
- Contact Name
- Laura Blair
- Address
- 10350 Park Meadows Drive
- City
- Lone Tree
- State
- CO
- ZIP
- 80124
- Country
- US
- [email protected]
- Phone
- 800 5235798
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Bone Conduction, Implanted | MAH | Class 2 | Ear, Nose, Throat | No | 2023-09-13 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2023-09-13 |
| Active Implantable Bone Conduction Hearing System | PFO | Class 2 | Ear, Nose, Throat | No | 2023-09-13 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2003-03-07 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2003-03-18 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2012-05-29 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2010-10-06 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2013-10-24 |
Proprietary Names
Instrument Case (Phase 2)
Osia 2 System
Ba400 14mm Abutment
Osscora Surgical Set
Baha Vistafix
ENT Surgical
Instrument Case
Baha BIA300 Implants with Abutments
SoundArc
Headband for Baha
Baha Attract
Baha BA400 Abutment
BA310 Abutment, BIA310 Implant/Abutment
Baha 6 Max Sound Processor
Baha Smart App
Baha Fitting Software 6
BAHA IMPLANT SYSTEM
Baha 5 SuperPower Sound Processor
Baha 5 Power
Cochlear Baha 7 System
Baha 7 Sound Processor and Accessories
Cochlear SoundBand
Baha Fitting Software 7
Cochlear Baha Remote Control
Cochlear Wireless Mini Microphone
Cochlear Wireless TV Streamer
Cochlear Wireless Phone Clip
Cochlear Baha Control App
Mini Microphone Pro
Mini Microphone 2
Cochlear Osia® System
Cochlear Baha® Fitting Software 6
Cochlear Baha® Baha Smart App
Cochlear Baha® System
Baha 5
Cochlear OsiaTM System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device