FDA Registration
Active
🇲🇽 Mexico
Charger 1 miniBTE R (SBO Hearing)
Reg #: 3017441596
·
FEI: 3017441596
·
Expires 2025
Products
1
Proprietary Names
188
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Demant Operations, S.a. De C.v.
- Registration Number
- 3017441596
- FEI Number
- 3017441596
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Boulevard Corredor Tijuana-Rosarito 2000, #24702 H-1, Ejido Francisco Villa
- City
- Tijuana Baja California
- Country
- MX
Owner / Operator
- Firm Name
- DEMANT A/S
- Operator Number
- 8010048
- Address
- KONGEBAKKEN 9, --
- City
- SMORUM
- State
- DK-NOTA
- Postal Code
- DK-2765
- Country
- DK
- Correspondent
- Veronique Schou
US Agent
- Business Name
- Oticon Inc.
- Contact Name
- Love Aggarwal
- Address
- 580 Howard Ave
- City
- Somerset
- State
- NJ
- ZIP
- 08873
- Country
- US
- [email protected]
- Phone
- 732 8534740
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2012-11-16 |
Proprietary Names
Charger 1 miniBTE R (SBO Hearing)
Oticon Jet PX (SBO Hearing)
Neutral Oasisnxt Custom (SBO Hearing)
GPL CROS MNR T R (SBO Hearing)
Inizia 3 (Bernafon)
OPUS 1 (Bernafon)
Zerena 7 (Bernafon)
SoundLink2 App (Sonic)
BEFLEX (Bernafon)
HEARTOO1 (Bernafon)
ACRIVA 9 (Bernafon)
SAPHIRA 5 (Bernafon)
SoundLink 2 App (Sonic)
Alta 2 (Oticon)
Opn1 (Oticon)
OASIS (Bernafon)
ACRIVA 7 (Bernafon)
Opn2 (Oticon)
Nera2 (Oticon)
Philips HearLink App (SBO Hearing)
Pep family (Sonic)
Leox (Bernafon)
Oticon ON App (Oticon)
Philips HearSuite (Philips)
Zerena 3 (Bernafon)
CARISTA 3 (Bernafon)
lno (Oticon)
Genie 2 (Oticon)
Ria (Oticon)
XTREME (Bernafon)
Ria2 Pro (Oticon)
CROS (Oticon)
Xceed Play (Oticon)
Oticon RemoteCare (Oticon)
Xceed (Oticon)
HearLink000 (Philips)
Oticon Connectline Phone-Adapter 2 (Oticon)
Viron 1 (Bernafon)
Zerena 1 (Bernafon)
Enchant family (Sonic)
JUNA 7 (Bernafon)
Sensei Pro (Oticon)
Genie (Oticon)
Ria Pro (Oticon)
Alta2 Pro (Oticon)
Coral (Bernafon)
OASIS nxt (Bernafon)
Dynamo (Oticon)
CARISTA 5 (Bernafon)
SUPREMIA 3 (Bernafon)
Get (Oticon)
Charger miniRITE T R BL Bernafon (SBO Hearing)
SUPREMIA 7 (Bernafon)
EXPRESSfit (Sonic)
HearLink010 (Philips)
Opn3 (Oticon)
HEARTOO STUDIO (Bernafon)
SAPHIRA 3 (Bernafon)
Trek (Sonic)
Cheer family (Sonic)
Zerena 9 (Bernafon)
Journey family (Sonic)
Sensei (Oticon)
Zerena 5 (Bernafon)
SUMO (Oticon)
Captivate family (Sonic)
Nera2 Pro (Oticon)
Chili (Oticon)
EXPRESSfit PRO (Sonic)
SoundGate 3 (Sonic)
Bernafon EasyControl Connect (Bernafon)
Acto Pro (Oticon)
Ria2 (Oticon)
Sonic SoundLink Connect (Sonic)
Oticon More (SBO Hearing)
EasyControl-A App (Bernafon)
Oticon Remote Control 3 (Oticon)
lnizia 1 (Bernafon)
NEVARA 1 (Bernafon)
Oticon Medical Streamer Pro XM (Oticon)
HearLink020 (Philips)
Viron 3 (Bernafon)
Oticon EduMic (Oticon)
JUNA 9 (Bernafon)
Philips TV Adapter (Philips)
Sonic RC-A (Sonic)
Sonic TV Adapter 3 (Sonic)
Philips AudioClip (Philips)
Bernafon RC-A (Bernafon)
Sonic Radiant (SBO Hearing)
Oticon SmartCharger miniRITE R (SBO Hearing)
HearLink030 (SBO Hearing)
Bernafon Charger Plus MNR T R (SBO hearing)
Oticon Connectline Microphone (Oticon)
EXPRESSlink 3 (Sonic)
Capto (Bernafon)
Ruby (Oticon)
Viron 5 (Bernafon)
Viron 7 (Bernafon)
Oticon Medical Streamer (Oticon)
Viron 9 (Bernafon)
Oticon CROS PX miniRITE R (SBO Hearing)
ConnectClip (Oticon)
Sonic SoundClip-A (Sonic)
Oticon Charger 1 miniBTE R (SBO Hearing)
Sonic TV-A (Sonic)
Oticon Play PX (SBO hearing)
Sonic RC-N (Sonic)
Charger miniRITE T R BL Sonic (SBO Hearing)
Bernafon TV Adapter 2 (Bernafon)
Oticon TV Adapter 2 (Oticon)
Oticon Remote Control 2 (Oticon)
Charger 1 Oticon miniRITE R (SBO Hearing)
Philips Charger Plus MNR T R (SBO Hearing)
Bernafon RC-N (Bernafon)
Charger miniRITE T R BL Philips (SBO Hearing)
Remote Control (Philips)
Bernafon Alpha (SBO Hearing)
Oticon TV Adapter 3 (Oticon)
Oticon DAI Adapter (Oticon)
Bernafon TV-A (Bernafon)
Oticon Streamer Pro 1.3A (Oticon)
Oticon FM Adapter (Oticon)
Bernafon CROS MNR T R (SBO Hearing)
Philips HearLink CROS MNR T R (SBO Hearing)
Philips HearLink Connect (Philips)
Bernafon SoundClip-A (Bernafon)
Sonic CROS MNR T R (SBO Hearing)
Charger Plus MNR T R (SBO Hearing)
Oticon Zircon (SBO Hearing)
CROS MNR T R (SBO Hearing)
Sonic Charger Plus MNR T R (SBO Hearing)
Sonic Charger Plus MNB T R (SBO Hearing)
FW Updater App (SBO Hearing)
Philips Charger MNB T R (SBO Hearing)
Sonic Charger MNB T R (SBO Hearing)
MIRUM 3 (Bernafon)
AGXO F (SBO Hearing)
Bernafon Alpha XT (SBO Hearing)
Charger Plus MNB T R (SBO Hearing)
CAPTO 5 (Bernafon)
AGXO E (SBO Hearing)
Sonic Radiant SE (SBO Hearing)
Philips HearLink 50 (SBO Hearing)
Oticon Companion (SBO Hearing)
CAPTO 3 (Bernafon)
EarQ F (SBO Hearing)
Oticon Genie 2 (SBO Hearing)
Charger MNR (SBO Hearing)
Oticon SmartCharger miniBTE R (SBO Hearing)
Bernafon Charger Plus MNR (SBO Hearing)
Bernafon App (SBO Hearing)
Celebrate family (Sonic)
Charger miniRITE (SBO Hearing)
EarQ G S (Oticon)
Oticon Real (SBO Hearing)
Oticon Intent (SBO Hearing)
Bernafon Charger MNR (SBO Hearing)
Bernafon Oasisnxt (SBO Hearing)
AGXO Hearing B (SBO Hearing)
Sonic ExpressfitPro (SBO Hearing)
Philips HearSuite (SBO Hearing)
AGXO G S (Oticon)
Charger Plus MNR (SBO Hearing)
HHM G S (Oticon)
AGXO B (SBO Hearing)
RemoteLink 2 (SBO Hearing)
SoundLink 3 (SBO Hearing)
Charger 1 HHM miniRITE R (SBO Hearing)
Oticon Jet (SBO Hearing)
Neutral TV-A (SBO Hearing)
Neutral Charger Plus MNR T R (SBO Hearing)
Philips HearLink 40 (SBO Hearing)
AudigyFit 2 (SBO Hearing)
Bernafon Entra B (SBO Hearing)
Neutral Charger Plus MNB T R (SBO Hearing)
SmartCharger miniRITE (SBO Hearing)
Bernafon Encanta (SBO Hearing)
Philips HearLink 2 (SBO Hearing)
Oticon SmartCharger miniRITE (SBO Hearing)
Oticon Own SI (SBO Hearing)
Oticon Charger miniRITE (SBO Hearing)
Neutral Charger MNB T R (SBO Hearing)
Neutral Charger miniRITE T R BL (SBO Hearing)
Neutral SoundClip-A (SBO Hearing)
Neutral RC-A (SBO Hearing)
Birdsong AOXT (SBO Hearing)
SmartCharger miniRITE R (SBO Hearing)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device