Data / Medical devices / Denmark / WS Audiology A/S
WS Audiology A/S: FDA-registered device maker in Lynge Hovedstaden, Denmark, 1 510(k) clearance
WS Audiology A/S is registered with the FDA (registration 8021514) in Lynge Hovedstaden, Denmark. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 5, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8021514
- FEI number
- 3003557127
- Address
- Nymoellevej 6, Lynge Hovedstaden, Denmark, DK-3540
- Owner or operator
- WS Audiology A/S (8021514)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 19, 2001
- Registered through
- 2026
- Brand names listed
- Widex, Widex Allure, Widex CROS, Widex Enjoy, Widex Evoke, Widex Magnify, Widex Moment
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Masker, Tinnitus | KLW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 5, 2011 | K110973 | IE-ZEN (IN CLEAR SERIES HEARING AID) | KLW | Substantially Equivalent | Widex USA | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 31, 2018 | 81085 | Class II | Terminated | Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification de | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Masker, Tinnitus
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Hearing Aid, Air-Conduction, Prescription
Updated May 5, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.