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FDA Import/Export Information
- Establishment (Manufacturer) Name:
Audina Hearing Instrument - Establishment (Manufacturer) Registration Number:
1052698 - Establishment Operations:
Contract Manufacturer; Manufacturer - Owner/Operator Name:
Audina Hearing Instrument - Owner/Operator Number:
9000174 - Regulation Number:
874.3300 - Classification Name:
Hearing Aid, Air Conduction - Product Code:
ESD - Device Class:
1 - Medical Specialty:
Ear Nose & Throat - Medical Device Listing (LST):
E449176 - 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.
Importing Audina Products (for Returns)
| Description | Value |
|---|---|
| Commodity Harmonized Code | [9021.40.0000] Hearing Aids |
| [9021.90.0002] Hearing Aid Parts | |
| FDA Medical Device Listing (LST) | Audina: E449176 (Non-wireless) |
| Audina: D161232 (Wireless) | |
| FDA Product Code | ESD: Air Conduction Hearing Aids (Non-wireless) |
| OSM: Air Conduction Hearing Aids with wireless technology (Wireless) |