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
Phone
732 8534740

Products

Device Name Product Code
Hearing Aid, Air-Conduction With Wireless Technology, Prescription OSM

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