Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009307953

FEI Number

3009307953

Entity Name

Demant Operations Poland Sp. z o.o.

City/State/Country

Mierzyn Zachodniopomorskie, PL

Establishment Address

ul. Lubieszynska 59, Mierzyn Zachodniopomorskie 72-006, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DEMANT A/S (Owner Number: 8010048)

Owner / Operator Contact Address

KONGEBAKKEN 9, --, SMORUM, DK-NOTA DK-2765, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Screwdriver HexaDrive Sterilization cassette 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) Sonic Radiant (SBO Hearing) 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) Oticon Own (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) Ponto 4 Genie Medical BAHS Oticon SmartCharger miniRITE R (SBO Hearing) SmartCharger miniRITE R (SBO Hearing) SONIC AudigyFit 2 (SBO Hearing) Bernafon Oasisnxt (SBO Hearing) AGXO F (SBO Hearing) Oticon Genie 2 (SBO Hearing) Philips HearSuite (SBO Hearing) Neutral Oasisnxt Custom (SBO Hearing) Bernafon Entra B (SBO Hearing) Easy LE Adapter (Bernafon) Philips HearLink 50 (SBO Hearing) Oticon SmartCharger miniBTE R (SBO Hearing) Neutral Charger Plus MNB T R (SBO Hearing) CROS MNR TR (Bernafon) Birdsong A0 (SBO Hearing) EarQ F (SBO Hearing) AGXO B (SBO Hearing) Bernafon Encanta (SBO Hearing) BERNAFON Oticon Own SI (SBO Hearing) OTICON SmartCharger miniBTE R (SBO Hearing) Neutral Charger Plus MNR T R (SBO Hearing) 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) Ponto Bone Anchored Hearing System MONO Surgery Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2016-10-18
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2016-10-18
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2016-10-18
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2020-11-02
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2015-01-28
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2011-06-18
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2011-12-16
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2012-11-16
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2009-08-21
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2021-08-13
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2021-08-13
PFO	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	Class 2	874.3340	2024-07-11
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-10-14
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2015-02-11
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2019-05-09
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2019-05-09
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2019-05-09
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2004-04-12
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	1995-01-09
MAH	Hearing Aid, Bone Conduction, Implanted	Ear, Nose, Throat	Class 2	874.3302	2021-03-05

Official Correspondent

Veronique Schou

US Agent Details

Love Aggarwal Business: Oticon Inc. Email: lagg@demant.com Phone: (732) 8534740

Related Public Records

Same Entity

DEMANT A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3032579106	ITSA Medical	Vallauris Alpes-Maritimes, FR
3017441596	Demant Operations, S.a. De C.v.	Tijuana Baja California, MX
2240713	OTICON, INC.	SOMERSET, NJ, US
3002504821	MAICO Diagnostics GmbH	Berlin, DE
3005465494	Oticon A/S	Smorum Hovedstaden, DK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009307953. Last updated year: 2026. Please use registration number 3009307953 when referencing this establishment in official correspondence.