Widex A/S
Active in EUDAMEDDenmarkfrom SRN EUDAMED SRN DK-MF-000025153
- Devices
- 7,301
- Registrations
- EUDAMED
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
What Widex A/S makes
Widex A/S manufactures air-conduction hearing aids in multiple form factors, including receiver-in-canal, behind-the-ear, canal, and in-the-ear designs. Their portfolio also includes audiometric/hearing device software, noninvasive battery chargers, and remote controls for hearing aid/implant systems.
These devices are classified under Class I and Class II regulations and are listed in the FDA’s UDI (Unique Device Identification) database. The company is based in Denmark.
Catalogue
Search and filter all 7,301 devicesShowing 1-50 of 7,301
Company details
- EUDAMED SRN
- DK-MF-000025153
- DUNS number
- 309843613
- EU VAT number
- DK15771100
- EUDAMED status
- Active
- EUDAMED registered name
- Widex A/S
- Registered address
- 6, Nymøllevej, DK-3540, Lynge, Denmark
- Website
- www.wsa.com
- Phone
- +4544355600
- PRRC contact
- Katarzyna Bobrow
FDA recalls
FDA recall records list 1 recall initiated by Widex A/S, initiated on 2018-08-31. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 31 Aug 2018 Z-0094-2019 Class II Terminated The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
Frequently asked questions
How many devices does Widex A/S have in the registry?
The registry currently lists 7301 devices for Widex A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Widex A/S's devices?
Among its 50 most recently registered devices, Widex A/S has devices listed in EUDAMED (5 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Widex A/S's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Widex A/S's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Widex A/S?
FDA recall records list 1 recall initiated by Widex A/S, the most recent initiated on 31 Aug 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Widex A/S in the registry?
The most recently registered devices listed for Widex A/S include Widex WPP402, AGX D-FS, Widex U-CIC and Widex D-9.