Oticon Medical AB

FDA Device Registration & Listing · Askim Vastra Gotaland, SE · Registration 3007367732

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007367732
FEI Number
3007367732
Entity Name
Oticon Medical AB
City/State/Country
Askim Vastra Gotaland, SE
Establishment Address
Datavagen 37B, Askim Vastra Gotaland 43632, SE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
DEMANT A/S (Owner Number: 8010048)
Owner / Operator Contact Address
KONGEBAKKEN 9, --, SMORUM, DK-NOTA DK-2765, DK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211640
PMA Number
N/A

All Registered Proprietary Names

Ponto bone anchored hearing system Ponto Bone Anchored Hearing System Wide countersink, 3 mm Wide countersink, 4 mm Wide implant, 3 mm Wide implant, 4 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 Bone Anchored Hearing System MONO Surgery Kit Wide implant, 4 mm, with Abutment, 14 mm Abutment, 14 mm Ruler Genie Medical BAHS 2023.1 Genie Medical BAHS 2022.1 Ponto 5 SuperPower Softband 5 Genie Medical BAHS 2024.2 Instant SoundConnector 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 Ponto 4 Genie Medical BAHS 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 Genie Medical BAHS Ponto 5 Mini

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2011-06-18
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 2011-12-16
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2008-12-29
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2021-03-05
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2015-01-28
MAH Hearing Aid, Bone Conduction, Implanted Ear, Nose, Throat Class 2 874.3302 2022-01-11
LXB Hearing Aid, Bone Conduction Ear, Nose, Throat Class 2 874.3302 2022-01-11
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
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
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
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

Official Correspondent

No official correspondent registered.

US Agent Details

Laura Dixon Business: OTICON MEDICAL, LLC Email: ladi@oticonmedical.com Phone: (760) 9082393

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007367732. Last updated year: 2026. Please use registration number 3007367732 when referencing this establishment in official correspondence.
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