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Sign in to claim this brandWidex A/S
Denmark·DK-MF-000025153
Last updated May 24, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Widex A/S manufacture?
Widex A/S specializes in air-conduction hearing aids, offering multiple form factors such as 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 designed to address hearing loss and improve auditory function for users.
Where is Widex A/S based?
Widex A/S is headquartered in Denmark. The company’s location in Denmark reflects its focus on European and global markets for hearing healthcare solutions, though its devices are distributed and used worldwide.
Which regulatory registries list Widex A/S devices?
Widex A/S devices are listed in the FDA’s UDI (Unique Device Identification) database. This registry helps track and identify medical devices authorized for use in the United States, ensuring transparency and traceability for healthcare providers and regulators.
How are Widex A/S devices classified under regulatory standards?
Widex A/S devices fall under Class I and Class II regulatory classifications. Class I devices generally pose minimal risk and often require less stringent regulatory oversight, while Class II devices involve a higher level of risk and may require special controls or performance standards to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Denmark
- Address
- 6, Nymøllevej , Lynge, Denmark
- Website
- www.wsa.com
- —
- —
- [email protected]
- Phone
- +4544355600
- PRRC Contact
- Katarzyna Bobrow
- EUDAMED SRN
- DK-MF-000025153
- FDA FEI Number
- —
- DUNS Number
- 309843613
Catalogue (7245)
Page 23 of 145| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Widex | B-F2 | FDA UDI | Class II | Active |
| Coselgi | CMe5-BTE | FDA UDI | Class II | Active |
| Widex | D-9 | FDA UDI | Class II | Active |
| Widex | M-IP 440 | FDA UDI | Class II | Active |
| Widex | M2-CIC | FDA UDI | Class II | Active |
| Widex | E-XP | FDA UDI | Class II | Active |
| Widex | U-CIC | FDA UDI | Class II | Active |
| Widex | D-FA | FDA UDI | Class II | Active |
| Widex | D-PA | FDA UDI | Class II | Active |
| Widex | M3-m | FDA UDI | Class II | Active |
| Widex | M2-m | FDA UDI | Class II | Active |
| Widex | UNIQUE U-FP 100 | FDA UDI | Class II | Active |
| Widex | D-FA P | FDA UDI | Class II | Active |
| Widex | U-CIC | FDA UDI | Class II | Active |
| Widex | B-F2 | FDA UDI | Class II | Active |
| Widex | C4-PA | FDA UDI | Class II | Active |
| Widex | D-9 | FDA UDI | Class II | Active |
| Widex | D-FS | FDA UDI | Class II | Active |
| Coselgi | CMe15-CIC | FDA UDI | Class II | Active |
| Widex | MBB2 440 | EUDAMEDFDA UDI | Class II | Active |
| Widex | M-CIC M 30 | FDA UDI | Class II | Active |
| Agx | AGX U-FA | FDA UDI | Class II | Active |
| Widex | MRB0 100 | EUDAMEDFDA UDI | Class II | Active |
| Widex | D-PA | FDA UDI | Class II | Active |
| Widex | D-FA | FDA UDI | Class II | Active |
| Widex | UNIQUE U-FS 330 | FDA UDI | Class II | Active |
| Widex | E-IP | FDA UDI | Class II | Active |
| Widex | U-FS | FDA UDI | Class II | Active |
| Widex | U-FS | FDA UDI | Class II | Active |
| Widex | D-FA | FDA UDI | Class II | Active |
| Coselgi | CMe15-CIC | FDA UDI | Class II | Active |
| Widex | U-CIC | FDA UDI | Class II | Active |
| Widex | MBB2 330 | EUDAMEDFDA UDI | Class II | Active |
| Widex | MOMENT MRB0 330 | EUDAMEDFDA UDI | Class II | Active |
| Widex | D-FA P | FDA UDI | Class II | Active |
| Widex | MRB0 | FDA UDI | Class II | Active |
| Widex | M3-m | FDA UDI | Class II | Active |
| Widex | MRB2D | EUDAMEDFDA UDI | Class II | Active |
| Widex | MRR2D | FDA UDI | Class II | Active |
| Widex | MOMENT MRB0 110 | EUDAMEDFDA UDI | Class II | Active |
| Widex | D-FA P | FDA UDI | Class II | Active |
| Widex | UNIQUE U-FS 110 | FDA UDI | Class II | Active |
| Widex | D-CIC-M | FDA UDI | Class II | Active |
| Widex | MBB2 330 | EUDAMEDFDA UDI | Class II | Active |
| Widex | E-FS | FDA UDI | Class II | Active |
| Widex | U-CIC | FDA UDI | Class II | Active |
| Widex | U-FP | FDA UDI | Class II | Active |
| Widex | U-FA | FDA UDI | Class II | Active |
| Widex | UNIQUE U-FS 110 | FDA UDI | Class II | Active |
| Widex | U-FA | FDA UDI | Class II | Active |
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