FDA Registration
Active
🇵🇱 Poland
Demant Operations Poland Sp. z o.o.
Reg #: 3009307953
·
FEI: 3009307953
·
Expires 2026
Products
9
Proprietary Names
382
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- Demant Operations Poland Sp. z o.o.
- Registration Number
- 3009307953
- FEI Number
- 3009307953
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ul. Lubieszynska 59
- City
- Mierzyn Zachodniopomorskie
- Country
- PL
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 |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2016-10-18 |
| Hearing Aid, Bone Conduction, Implanted | MAH | Class 2 | Ear, Nose, Throat | No | 2016-10-18 |
| Hearing Aid, Bone Conduction | LXB | Class 2 | Ear, Nose, Throat | No | 2016-10-18 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2020-11-02 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2012-11-16 |
| Active Implantable Bone Conduction Hearing System | PFO | Class 2 | Ear, Nose, Throat | No | 2024-07-11 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2014-10-14 |
| Masker, Tinnitus | KLW | Class 2 | Ear, Nose, Throat | No | 2015-02-11 |
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 1995-01-09 |
Proprietary Names
Ponto 3 Power, R, STG
Ponto Soft band, grey
Ponto Soft band, bilateral, grey
Ponto SoundConnector
Ponto 3, R, PUW
Ponto 3 Power, R, PUW
Ponto 3 SuperPower Demo, R, CBE
Genie Medical
Ponto 3 SuperPower, L, STG
Ponto Soft band, bilateral, blue
Ponto 3 SuperPower, R, WHS
Ponto Soft band, bilateral, indigo
Ponto 3 SuperPower, R, CBE
Ponto Soft band, bilateral, purple
Ponto 3 Power, L, DBL
Ponto 3 SuperPower, L, MBR
Ponto Soft band, red
Ponto Soft band, bilateral, red
Ponto 3 SuperPower, L, CBE
Ponto Soft band, cerise
Ponto Soft band, bilateral, cerise
Ponto 3, R, DBL
Ponto 3 Power, R, DBL
Ponto 3, R, MBR
Ponto 3 Power, R, MBR
Ponto Soft band, purple
Demo BL Oticon Medical Streamer
Ponto 3 Demo, R, CBE
Ponto 3 SuperPower, R, DBL
Ponto Soft band, yellow
Ponto Soft band, bilateral, yellow
Ponto 3 Power, R, CBE
Ponto Soft band, indigo
Ponto 3 SuperPower, L, WHS
Ponto Soft band, bilateral, navy
Ponto Soft band, black
Ponto Soft band, bilateral, black
Ponto 3 Power, L, PUW
Ponto Soft band, brown
Ponto Soft band, bilateral, brown
Ponto 3, L, CBE
Ponto 3 Power, L, CBE
Ponto Soft band, navy
Ponto 3 Power, L, STG
Ponto Soft band, green
Ponto 3 Power, R, WHS
Ponto Soft band, turquoise
Ponto 3 SuperPower, R, MBR
Ponto Soft band, pink
Ponto Soft band, bilateral, pink
Ponto Soft band, bilateral, beige
Ponto 3 Demo, L, CBE
Ponto 3 SuperPower, L, DBL
Ponto Soft band, beige
Ponto 3, R, CBE
Ponto 3 Power, L, WHS
Ponto Soft band, blue
Ponto 3, L, STG
Ponto 3 SuperPower, L, PUW
Ponto 3, L, MBR
Ponto 3 Power, L, MBR
BL Oticon Medical Streamer
Ponto Soft band, bilateral, green
Ponto 3, L, DBL
Ponto 3, L, WHS
Ponto 3, R, WHS
Ponto 3 SuperPower, R, STG
Ponto 3, R, STG
Ponto 3 SuperPower, R, PUW
Ponto 3, L, PUW
Ponto 3 SuperPower Demo, L, CBE
WH Oticon Medical Streamer
Ponto Soft band, bilateral, turquoise
Torque Wrench
Screwdriver HexaDrive
Wide implant, 4 mm, with Abutment, 14 mm
Abutment, 14 mm
Ruler
Ponto bone anchored hearing system
Wide countersink, 3 mm
Wide countersink, 4 mm
Wide implant, 3 mm
Wide implant, 4 mm
SoundLink 2 App (Sonic)
Alta2 Pro (Oticon)
lnizia 1 (Bernafon)
Genie (Oticon)
Philips HearSuite (Philips)
lno (Oticon)
OASIS nxt (Bernafon)
HearLink 010 BTE (SBO Hearing)
SUMO (Oticon)
XTREME BTE (SBO Hearing)
Ria Pro (Oticon)
CROS (Oticon)
Genie 2 (Oticon)
Ria (Oticon)
Ria2 Pro (Oticon)
HEARTOO1 (Bernafon)
Zerena 3 (Bernafon)
Journey family (Sonic)
Zerena 5 (Bernafon)
Viron 9 (Bernafon)
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)
Zerena 7 (Bernafon)
NEVARA 1 (Bernafon)
ACRIVA BTE (SBO Hearing)
Chili (Oticon)
Opn BTE (SBO Hearing)
EXPRESSfit PRO (Sonic)
Zerena 9 (Bernafon)
Enchant family (Sonic)
Ria2 (Oticon)
Oticon Nera2 (SBO Hearing)
BEFLEX (Bernafon)
HearLink020 (Philips)
Acto Pro (Oticon)
Pep family (Sonic)
Nera2 Pro (Oticon)
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)
Viron 1 (Bernafon)
Get (Oticon)
Zerena 1 (Bernafon)
Oticon ON App (Oticon)
Xceed Play (Oticon)
Bernafon Alpha BTE (SBO Hearing)
Sonic SoundClip-A (Sonic)
Philips HearLink App (SBO Hearing)
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)
Sonic Radiant (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)
Capto (Bernafon)
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)
AGXO F (SBO Hearing)
Sonic Radiant SE (SBO Hearing)
Oticon Zircon (SBO Hearing)
Oticon Real (SBO Hearing)
Bernafon Alpha XT (SBO Hearing)
CAPTO 5 (Bernafon)
Charger Plus MNB T R (SBO Hearing)
HHM G S (Oticon)
Celebrate family (Sonic)
Oticon Jet (SBO Hearing)
AGXO G S (Oticon)
RemoteLink 2 (SBO Hearing)
Intent BTE (SBO Hearing)
Oticon Charger miniRITE (SBO Hearing)
Bernafon Charger MNR (SBO Hearing)
Sonic Charger Plus MNB T R (SBO Hearing)
Oticon Companion App (SBO Hearing)
CAPTO 3 (Bernafon)
Philips HearLink 40 (SBO Hearing)
EarQ F BTE (SBO Hearing)
Bernafon Encanta (SBO Hearing)
Oticon SmartCharger miniRITE (SBO Hearing)
Charger MNR (SBO Hearing)
AGXO E BTE (SBO Hearing)
Charger Plus MNR (SBO Hearing)
Bernafon Entra B BTE (SBO Hearing)
Philips HearLink 50 (SBO Hearing)
Bernafon App (SBO Hearing)
AGXO Hearing B (SBO Hearing)
Charger miniRITE (SBO Hearing)
AGXO B BTE (SBO Hearing)
Neutral RC-A (SBO Hearing)
Bernafon Charger Plus MNR (SBO Hearing)
AudigyFit 2 (SBO Hearing)
Neutral Oasisnxt Custom (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)
Philips HearSuite (SBO Hearing)
Oticon Genie 2 (SBO Hearing)
Bernafon Oasisnxt (SBO Hearing)
SmartCharger miniRITE (SBO Hearing)
Sonic ExpressfitPro (SBO Hearing)
Philips HearLink 2 (SBO Hearing)
Oticon Zeal (SBO Hearing)
EarQ G S (Oticon)
Charger Plus nxtCIC R (SBO Hearing)
Bernafon Charger Plus MNB R (SBO Hearing)
Birdsong AO BTE (SBO Hearing)
SmartCharger nxtCIC R (SBO Hearing)
Birdsong Harmony A1
Neutral Charger MNB T R (SBO Hearing)
Oticon Verit (SBO Hearing)
Oticon SmartCharger Pro miniRITE (SBO Hearing)
Neutral Charger Plus MNB T R (SBO Hearing)
Birdsong App (SBO Hearing)
SmartCharger miniRITE R (SBO Hearing)
Neutral TV-A (SBO Hearing)
Oticon SmartCharger nxtCIC R (SBO Hearing)
Neutral Charger miniRITE T R BL (SBO Hearing)
Oticon Own SI (SBO Hearing)
Bernafon Charger Plus nxtCIC R (SBO Hearing)
GPL CROS MNR T R (SBO Hearing)
Birdsong AOXT (SBO Hearing)
SmartCharger miniBTE R (SBO Hearing)
Bernafon Charger MNB R (SBO Hearing)
Neutral Charger Plus MNR T 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)
Ponto Bone Anchored Hearing System
Genie Medical BAHS
Ponto 5 Mini
Sentio 1 Mini, DBL
Spare Fixation Screws
Sentio Ti Implant Kit
Sentio 1 Mini, CBE
Sentio 1 Mini, SIL
Sentio 1 Mini, STG
Sentio 1 Mini, TC
Genie Medical BAHS 2024.2
Sentio 1 Mini, CNB
Genie Medical BAHS 2023.1
Sentio Position Marker, non-sterile
Sterilization cassette
AGXO B (SBO Hearing)
Alta2 Pro TI (Oticon)
Viron 7 (Bernafon)
Nera2 Pro TI (Oticon)
Ria2 Pro Tl (Oticon)
Opn 3 (Oticon)
Opn 2 (Oticon)
EasyControl-A (Bernafon)
Ruby (Oticon)
Siya (Oticon)
Captivate (Sonic)
SoundLink2 App (Sonic)
Opn S (Oticon)
Viron 5 (Bernafon)
Oticon Genie2 (Oticon)
Alta2 (Oticon)
Opn 1 (Oticon)
Opn Play (Oticon)
Oticon More (SBO Heraing)
Viron 3 (Bernafon)
Nera2 (Oticon)
Coral (Bernafon)
Bernafon Alpha (SBO Hearing)
Sonic Expressfit Pro (Sonic)
Bernafon OasisNxt (Bernafon)
Oticon Own (SBO Hearing)
EarQ F (SBO Hearing)
Oticon Intent (SBO Hearing)
SoundLink 3 (SBO Hearing)
Oticon Companion (SBO Hearing)
Oticon Jet PX (SBO Hearing)
AGXO E (SBO Hearing)
Oticon Play SI (SBO Hearing)
Birdsong A0 (SBO Hearing)
Bernafon Entra B (SBO Hearing)
AGXO F (SBO HEARING)
Ponto 4
SONIC
Easy LE Adapter (Bernafon)
CROS MNR TR (Bernafon)
BERNAFON
OTICON
Oticon Ria2 Pro (SBO Hearing)
Oticon Ria Pro (SBO Hearing)
Oticon Nera2 Pro (SBO Hearing)
Oticon Get (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)
MONO Surgery Kit
Wide implant, 4 mm, with Abutment, 9 mm
Wide implant, 3 mm, with Abutment, 9 mm
Wide implant, 4 mm, with Abutment, 6mm
Wide implant, 3 mm, with Abutment, 6 mm
Abutment, 6 mm
Abutment, 12mm
Wide implant, 4 mm, with Abutment, 12 mm
Abutment, 9 mm
Soft band, Black
Head band
Healing cap
Square fit connection, machine
Handle with screwdriver
Abutment inserter, machine
Soft band, Navy blue
Soft band, Light blue
Soft band, Pink
Counter torque wrench
Soft band, bilateral, Black
Screwdriver hexagon
Soft band, bilateral, Pink
Sound processor indicator
Soft band, bilateral, Navy blue
Screwdriver, machine
Guide drill, 3 - 4 mm
Soft band, bilateral, Beige
Soft band, bilateral, Red
Soft band, Red
Soft band, Beige
Soft band, bilateral, Light blue
Test band
Cover screw hexagon
Ponto BHX Implant, 4 mm, with abutment, 9 mm
Ponto BHX Implant, 4 mm, with abutment, 14 mm
Ponto BHX Implant, 4 mm
Ponto BHX Implant, 3 mm, with abutment, 9 mm
Ponto BHX Implant, 3 mm, with abutment, 6 mm
Ponto BHX Implant, 4 mm, with abutment, 6 mm
MIPS Surgery kit, 4 mm
Double-ended dissector
Ponto BHX Implant, 3 mm
MIPS Back-up kit, 3 mm
Soft healing cap
Ponto BHX Implant, 4 mm, with abutment, 12 mm
Genie Medical BAHS 2022.1
Ponto 5 SuperPower
Softband 5
Instant SoundConnector
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device