FDA Registration
Active
🇲🇽 Mexico
Demant Operations, S.a. De C.v.
Reg #: 3017441596
·
FEI: 3017441596
·
Expires 2026
Products
4
Proprietary Names
234
Establishment Types
3
Classifications
4
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Registration Details
- Registration Name
- Demant Operations, S.a. De C.v.
- Registration Number
- 3017441596
- FEI Number
- 3017441596
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Boulevard Corredor Tijuana-Rosarito 2000, #24702 H-1, Ejido Francisco Villa
- City
- Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K133308
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 |
|---|---|---|---|---|---|
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 1995-01-09 |
| Masker, Tinnitus | KLW | Class 2 | Ear, Nose, Throat | No | 2015-02-11 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2012-11-16 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2004-04-12 |
Proprietary Names
Oticon Nera2 (SBO Hearing)
Oticon Ria2 Pro (SBO Hearing)
Oticon Ria Pro (SBO Hearing)
Oticon Nera2 Pro (SBO Hearing)
Oticon Get (SBO Hearing)
Philips HearLink App (SBO Hearing)
Bernafon RC-A (SBO Hearing)
Oticon Opn (SBO Hearing)
Oticon Ria2 (SBO Hearing)
Sonic Enchant SE (SBO Hearing)
Philips HearLink 30 (SBO Hearing)
Sonic Radiant (SBO Hearing)
Oticon Own (SBO Hearing)
AGXO B (SBO Hearing)
Neutral Oasisnxt Custom (SBO Hearing)
Alta2 Pro TI (Oticon)
Viron 7 (Bernafon)
Nera2 Pro TI (Oticon)
Ria2 Pro Tl (Oticon)
Opn 3 (Oticon)
Opn 2 (Oticon)
Zerena 1 (Bernafon)
Zerena 7 (Bernafon)
EasyControl-A (Bernafon)
Ruby (Oticon)
Siya (Oticon)
Zerena 5 (Bernafon)
Captivate (Sonic)
Viron 9 (Bernafon)
Nera2 Pro (Oticon)
Ria2 (Oticon)
Enchant family (Sonic)
SoundLink2 App (Sonic)
Opn S (Oticon)
Viron 5 (Bernafon)
Oticon Genie2 (Oticon)
Alta2 (Oticon)
Opn 1 (Oticon)
Opn Play (Oticon)
Zerena 3 (Bernafon)
Ria2 Pro (Oticon)
Oticon More (SBO Heraing)
Viron 1 (Bernafon)
Alta2 Pro (Oticon)
Ria Pro (Oticon)
Viron 3 (Bernafon)
Ria (Oticon)
Nera2 (Oticon)
Zerena 9 (Bernafon)
Coral (Bernafon)
Bernafon Alpha (SBO Hearing)
Capto (Bernafon)
Sonic Expressfit Pro (Sonic)
Bernafon OasisNxt (Bernafon)
Oticon ON App (Oticon)
Oticon Zircon (SBO Hearing)
Philips HearSuite (SBO Hearing)
AGXO F (SBO Hearing)
Bernafon App (SBO Hearing)
CAPTO 5 (Bernafon)
Sonic ExpressfitPro (SBO Hearing)
EarQ F (SBO Hearing)
Philips HearLink 2 (SBO Hearing)
Oticon Intent (SBO Hearing)
SoundLink 3 (SBO Hearing)
Bernafon Alpha XT (SBO Hearing)
Oticon Charger miniRITE (SBO Hearing)
Oticon Genie 2 (SBO Hearing)
Charger miniRITE (SBO Hearing)
AudigyFit 2 (SBO Hearing)
Bernafon Charger Plus MNR (SBO Hearing)
Sonic Radiant SE (SBO Hearing)
EarQ G S (Oticon)
Bernafon Encanta (SBO Hearing)
Bernafon Charger MNR (SBO Hearing)
SmartCharger miniRITE (SBO Hearing)
Neutral RC-A (SBO Hearing)
Oticon Companion (SBO Hearing)
Oticon Real (SBO Hearing)
Philips HearLink 50 (SBO Hearing)
Oticon Jet PX (SBO Hearing)
AGXO G S (Oticon)
RemoteLink 2 (SBO Hearing)
Neutral Charger Plus MNR T R (SBO Hearing)
AGXO E (SBO Hearing)
AGXO Hearing B (SBO Hearing)
Bernafon Oasisnxt (SBO Hearing)
Birdsong App (SBO Hearing)
Charger Plus MNR (SBO Hearing)
Philips HearLink 40 (SBO Hearing)
CAPTO 3 (Bernafon)
HHM G S (Oticon)
Oticon Play SI (SBO Hearing)
Oticon SmartCharger miniRITE (SBO Hearing)
Birdsong A0 (SBO Hearing)
Bernafon Entra B (SBO Hearing)
Oticon Verit (SBO Hearing)
Charger MNR (SBO Hearing)
Birdsong AOXT (SBO Hearing)
Birdsong Harmony A1
Oticon Own SI (SBO Hearing)
Neutral TV-A (SBO Hearing)
AGXO F (SBO HEARING)
Neutral Charger Plus MNB T R (SBO Hearing)
SoundLink 2 App (Sonic)
lnizia 1 (Bernafon)
Genie (Oticon)
Philips HearSuite (Philips)
lno (Oticon)
OASIS nxt (Bernafon)
HearLink 010 BTE (SBO Hearing)
SUMO (Oticon)
XTREME BTE (SBO Hearing)
CROS (Oticon)
Genie 2 (Oticon)
HEARTOO1 (Bernafon)
Journey family (Sonic)
Inizia 3 (Bernafon)
Leox BTE (SBO Hearing)
Oticon RemoteCare (Oticon)
HearLink 000 BTE (SBO Hearing)
Oticon EduMic (SBO Hearing)
EXPRESSlink 3 (Sonic)
Oticon Connectline Phone-Adapter 2 (Oticon)
Dynamo (Oticon)
NEVARA 1 (Bernafon)
ACRIVA BTE (SBO Hearing)
Chili (Oticon)
Opn BTE (SBO Hearing)
EXPRESSfit PRO (Sonic)
BEFLEX (Bernafon)
HearLink020 (Philips)
Acto Pro (Oticon)
Pep family (Sonic)
Sensei Pro (Oticon)
SUPREMIA BTE (SBO Hearing)
Sensei (Oticon)
JUNA 9 (Bernafon)
ACRIVA 9 (Bernafon)
OPUS 1 (Bernafon)
SoundGate 3 (Sonic)
JUNA 7 (Bernafon)
CARISTA BTE (SBO Hearing)
Bernafon RC-A (Bernafon)
Oticon Remote Control 3 (Oticon)
Trek (Sonic)
Xceed (Oticon)
Captivate BTE (SBO Hearing)
Oticon More (SBO Hearing)
OASIS (Bernafon)
Opn2 (Oticon)
Viron BTE (SBO Hearing)
Oticon Connectline Microphone (Oticon)
SAPHIRA BTE (SBO Hearing)
EXPRESSfit (Sonic)
Philips AudioClip (Philips)
Get (Oticon)
Xceed Play (Oticon)
Bernafon Alpha BTE (SBO Hearing)
Sonic SoundClip-A (Sonic)
Ruby BTE (SBO Hearing)
Philips TV Adapter (SBO Hearing)
ConnectClip (SBO Hearing)
Charger miniRITE T R BL Sonic (SBO Hearing)
Charger 1 Oticon miniRITE R (SBO Hearing)
Philips HearLink CROS MNR T R (SBO Hearing)
Oticon Medical Streamer Pro XM (SBO Hearing)
Philips Charger Plus MNR T R (SBO Hearing)
Coral BTE (SBO Hearing)
Charger miniRITE T R BL Bernafon (SBO Hearing)
Sonic Charger Plus MNR T R (SBO Hearing)
Sonic RC-A (Sonic)
HearLink030 (SBO Hearing)
Bernafon CROS MNR T R (SBO Hearing)
Bernafon Charger Plus MNR T R (SBO hearing)
Oticon DAI Adapter (Oticon)
Bernafon TV Adapter 2 (Bernafon)
Bernafon SoundClip-A (Bernafon)
Philips Charger MNB T R (SBO Hearing)
Oticon TV Adapter 3 (SBO Hearing)
Bernafon TV-A (SBO Hearing)
Sonic CROS MNR T R (SBO Hearing)
Oticon FM Adapter (SBO Hearing)
Remote Control (Philips)
Charger miniRITE T R BL Philips (SBO Hearing)
Sonic TV-A (Sonic)
Philips HearLink Connect (Philips)
CROS MNR T R (SBO Hearing)
Charger Plus MNR T R (SBO Hearing)
Oticon SmartCharger miniRITE R (SBO Hearing)
Oticon Medical Streamer (Oticon)
Oticon SmartCharger miniBTE R (SBO Hearing)
Oticon CROS PX miniRITE R (SBO Hearing)
MIRUM 3 (Bernafon)
Sonic Charger MNB T R (SBO Hearing)
Oticon Charger 1 miniBTE R (SBO Hearing)
Oticon Play PX BTE (SBO hearing)
Charger Plus MNB T R (SBO Hearing)
Celebrate family (Sonic)
Oticon Jet (SBO Hearing)
Intent BTE (SBO Hearing)
Sonic Charger Plus MNB T R (SBO Hearing)
Oticon Companion App (SBO Hearing)
EarQ F BTE (SBO Hearing)
AGXO E BTE (SBO Hearing)
Bernafon Entra B BTE (SBO Hearing)
AGXO B BTE (SBO Hearing)
Neutral SoundClip-A (SBO Hearing)
Oticon Jet PX BTE (SBO Hearing)
Oticon Charger miniBTE R (SBO Hearing)
Charger 1 HHM miniRITE R (SBO Hearing)
Oticon Zeal (SBO Hearing)
Charger Plus nxtCIC R (SBO Hearing)
Bernafon Charger Plus MNB R (SBO Hearing)
Birdsong AO BTE (SBO Hearing)
SmartCharger nxtCIC R (SBO Hearing)
Neutral Charger MNB T R (SBO Hearing)
Oticon SmartCharger Pro miniRITE (SBO Hearing)
SmartCharger miniRITE R (SBO Hearing)
Oticon SmartCharger nxtCIC R (SBO Hearing)
Neutral Charger miniRITE T R BL (SBO Hearing)
Bernafon Charger Plus nxtCIC R (SBO Hearing)
GPL CROS MNR T R (SBO Hearing)
SmartCharger miniBTE R (SBO Hearing)
Bernafon Charger MNB R (SBO Hearing)
Charger 1 miniBTE R (SBO Hearing)
Charger Plus MNB R (SBO Hearing)
Charger miniBTE R (SBO Hearing)
Oticon Play SI BTE (SBO Hearing)
SONIC
Easy LE Adapter (Bernafon)
CROS MNR TR (Bernafon)
BERNAFON
OTICON
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device