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shipping:fda_import_export_information [2017/07/19 10:31]
smayr [Bernafon] |
shipping:fda_import_export_information [2017/10/31 11:29] (current)
smayr [FDA Import/Export Information] |
| * Medical Specialty: ''Ear Nose & Throat'' | * Medical Specialty: ''Ear Nose & Throat'' |
| * Medical Device Listing (LST): ''E449176'' | * Medical Device Listing (LST): ''E449176'' |
| * FDA Record: [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=47626&lpcd=ESD]] | * FDA Record: [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=47626&lpcd=ESD|Main]] and [[https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=11708|Audina/Auditiva FDA Establishment Registration & Device Listing]] |
| * Product (Proprietary Names): ''478 BTE; 478P BTE; 478P+ BTE; AGC-o; AUDINA; Audina 675DP+; Audina Analog +; Audina Arro 2; Audina Arro 6; Audina Arro 6AD; Audina BTE D6HP; Audina BTE D6P; Audina BTE6AD; Audina BTED275; Audina Flx 4; Audina Flx 6; Audina Intuition 6; Audina Intuition 6AD; Audina IRIC 6; Audina OCTANE T; BTE 13D2; BTE D2; BTE D2HP; BTE DP; Class A; Class D; Cue; ezHEAR; FLX; FLX 2; Foundation; InstaFit; Intellio; Intuition 12; Intuition 12AD; Intuition 2; Intuition 2+; Intuition 2ER; Intuition 2FC; Intuition 2FC+; Intuition 4+; Intuition 4AD; IRIC 12; IRIC 2; IRIC 4; nVe; nVe AD; Octane; Octane 12; Octane 4; Opti Trim; Push Pull; Simplex; Simplex 2; Simplex 2P; Simplex 2P+; Simplex FC; Sparo; Sparo 12; Sparo 2; Sparo 2+; Sparo 2ER; Sparo AD; Super 60D''. | * Product (Proprietary Names): ''478 BTE; 478P BTE; 478P+ BTE; AGC-o; AUDINA; Audina 675DP+; Audina Analog +; Audina Arro 2; Audina Arro 6; Audina Arro 6AD; Audina BTE D6HP; Audina BTE D6P; Audina BTE6AD; Audina BTED275; Audina Flx 4; Audina Flx 6; Audina Intuition 6; Audina Intuition 6AD; Audina IRIC 6; Audina OCTANE T; BTE 13D2; BTE D2; BTE D2HP; BTE DP; Class A; Class D; Cue; ezHEAR; FLX; FLX 2; Foundation; InstaFit; Intellio; Intuition 12; Intuition 12AD; Intuition 2; Intuition 2+; Intuition 2ER; Intuition 2FC; Intuition 2FC+; Intuition 4+; Intuition 4AD; IRIC 12; IRIC 2; IRIC 4; nVe; nVe AD; Octane; Octane 12; Octane 4; Opti Trim; Push Pull; Simplex; Simplex 2; Simplex 2P; Simplex 2P+; Simplex FC; Sparo; Sparo 12; Sparo 2; Sparo 2+; Sparo 2ER; Sparo AD; Super 60D''. |
| |
| | | [9021.90.0002] Hearing Aid Parts | | | | [9021.90.0002] Hearing Aid Parts | |
| |
| ==== Audina ==== | ==== Audina (Non-wireless) ==== |
| ^ Description ^ Value ^ | ^ Description ^ Value ^ |
| | FDA Establishment Number | 1052698 | | | FDA Establishment Number | 1052698 | |
| | FDA Medical Device Listing (LST) | E449176 (Non-wireless) | | | FDA Medical Device Listing (LST) | E449176 | |
| | FDA Product Code | ESD: Air Conduction Hearing Aids (Non-wireless) | | | FDA Product Code | ESD: Air Conduction Hearing Aids | |
| |
| ==== Bernafon ==== | ==== Bernafon (Wireless) ==== |
| ^ Description ^ Value ^ | ^ Description ^ Value ^ |
| | FDA Establishment Number | 3002857991 | | | FDA Establishment Number | 3002857991 | |
| | FDA Medical Device Listing (LST) | D161232 (Wireless) | | | FDA Medical Device Listing (LST) | D161232 | |
| | FDA Product Code | OSM: Air Conduction Hearing Aids with wireless technology (Wireless) | | | FDA Product Code | OSM: Air Conduction Hearing Aids with wireless technology| |