FDA Registration
Active
🇺🇸 United States
Celebrate family (Sonic)
Reg #: 2240713
·
FEI: 2240713
·
Expires 2025
Products
1
Proprietary Names
52
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OTICON, INC.
- Registration Number
- 2240713
- FEI Number
- 2240713
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 580 Howard Avenue
- City
- SOMERSET
- State
- NJ
- ZIP
- 08873
- Country
- US
Owner / Operator
- Firm Name
- DEMANT A/S
- Operator Number
- 8010048
- Address
- KONGEBAKKEN 9, --
- City
- SMORUM
- State
- DK-NOTA
- Postal Code
- DK-2765
- Country
- DK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 1995-01-09 |
Proprietary Names
Celebrate family (Sonic)
Nera Pro (Oticon)
MOVE (Bernafon)
Zerena 5 (Bernafon)
Zerena 3 (Bernafon)
Pep family (Sonic)
Agil Pro (Oticon)
Acto Pro (Oticon)
Prio (Bernafon)
Nera (Oticon)
Zerena 7 (Bernafon)
Alta Pro (Oticon)
SAPHIRA 5 (Bernafon)
Opn3 (Oticon)
lno (Oticon)
Ria Pro (Oticon)
SoundLink 2 App family (Sonic)
JUNA 7 (Bernafon)
Alta (Oticon)
JUNA 9 (Bernafon)
Philips Hear-Link App (SBO Hearing)
HearLink000 (SBO Hearing)
Agil (Oticon)
NEVARA 1 (Bernafon)
Neo (Bernafon)
Nera2 Pro (Oticon)
Get (Oticon)
CARISTA 5 (Bernafon)
Enchant family (Sonic)
Inizia 3 (Bernafon)
Alta2 Pro (Oticon)
HEARTOO1 (Bernafon)
Inizia 1 (Bernafon)
Ria2 (Oticon)
Opn 1 (Oticon)
Zerena 1 (Bernafon)
SAPHIRA 3 (Bernafon)
CHRONOS 5 (Bernafon)
Opn 2 (Oticon)
Remote Control (Bernafon)
Zerena 9 (Bernafon)
ACRIVA 7 (Bernafon)
Nera2 (Oticon)
CARISTA 3 (Bernafon)
Alta2 (Oticon)
ACRIVA 9 (Bernafon)
Ria2 Pro (Oticon)
Oticon Own (SBO Hearing)
Sonic Radiant (SBO Hearing)
Philips HearLink 30 (SBO Hearing)
Cheer family (Sonic)
Charm family (Sonic)
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device