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Sign in to claim this brandHansaton Akustik GmbH
US
Last updated May 27, 2026
What Hansaton Akustik GmbH makes
The company manufactures air-conduction hearing aids in multiple form factors, including receiver-in-canal, behind-the-ear, canal, and in-the-ear designs. It also produces noninvasive battery chargers for these devices. The portfolio includes branded hearing aid models under the Hansaton name.
These devices are classified under FDA regulations as Class I and Class II, with listings in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
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 Hansaton Akustik GmbH manufacture?
Hansaton Akustik GmbH specializes in air-conduction hearing aids, offering multiple form factors such as receiver-in-canal, behind-the-ear, canal, and in-the-ear designs. Additionally, the company produces noninvasive battery chargers designed specifically for these hearing aid models. The portfolio includes branded hearing aids under the Hansaton name.
Where is Hansaton Akustik GmbH based?
Hansaton Akustik GmbH is based in the United States. This location is relevant for regulatory compliance and distribution, as the company’s devices are subject to U.S. regulatory requirements.
Which regulatory registries list Hansaton Akustik GmbH’s devices?
Hansaton Akustik GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring traceability and compliance with regulatory standards.
How are Hansaton Akustik GmbH’s hearing aids classified under FDA regulations?
Hansaton Akustik GmbH’s air-conduction hearing aids are classified under FDA regulations as either Class I or Class II. Class I devices generally pose minimal risk and require less stringent premarket review, while Class II devices involve moderate risk and may require special controls or performance standards to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- hansaton.com
- —
- —
- [email protected]
- Phone
- +49402980110
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 316040146
Catalogue (939)
Page 1 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hansaton | 050-6003-U7 | FDA UDI | Class II | Active |
| Hansaton | 050-6093-U6 | FDA UDI | Class II | Active |
| Hansaton | 82522 | FDA UDI | Class II | Active |
| Hansaton | 050-5742-U569 | FDA UDI | Class II | Active |
| Hansaton | 85209 | FDA UDI | Class I | Active |
| Hansaton | 050-5931-U3 | FDA UDI | Class II | Active |
| Hansaton | 050-6186-U6 | FDA UDI | Class II | Active |
| Hansaton | 063-5784-01 | FDA UDI | Class I | Active |
| Hansaton | 050-5711-U369 | FDA UDI | Class II | Active |
| Hansaton | 82533 | FDA UDI | Class II | Active |
| Hansaton | 050-5744-U3 | FDA UDI | Class II | Active |
| Hansaton | 050-6181-S8 | FDA UDI | Class II | Active |
| Hansaton | 050-6187-U8 | FDA UDI | Class II | Active |
| Hansaton | 050-6087-U9 | FDA UDI | Class II | Active |
| Hansaton | 050-6005-U5 | FDA UDI | Class II | Active |
| Hansaton | 050-5747-U969 | FDA UDI | Class II | Active |
| Hansaton | 050-6086-U5 | FDA UDI | Class II | Active |
| Hansaton | 075-5107-11 | FDA UDI | Class II | Active |
| Hansaton | 050-5998-U9 | FDA UDI | Class II | Active |
| Hansaton | 83461 | FDA UDI | Class I | Active |
| Hansaton | 050-6180-U4 | FDA UDI | Class II | Active |
| Hansaton | 050-5626-U446 | FDA UDI | Class II | Active |
| Hansaton | 050-5701-U846 | FDA UDI | Class II | Active |
| Hansaton | 050-6001-U669 | FDA UDI | Class II | Active |
| Hansaton | 050-5861-U646 | FDA UDI | Class II | Active |
| Hansaton | 050-5925-U6 | FDA UDI | Class II | Active |
| Hansaton | 050-6024-U4 | FDA UDI | Class II | Active |
| Hansaton | 050-5742-U4 | FDA UDI | Class II | Active |
| Hansaton | 050-5746-U669 | FDA UDI | Class II | Active |
| Hansaton | 050-5935-U4 | FDA UDI | Class II | Active |
| Hansaton | 050-5713-U369 | FDA UDI | Class II | Active |
| Hansaton | 050-6188-U6 | FDA UDI | Class II | Active |
| Hansaton | 050-5997-U6 | FDA UDI | Class II | Active |
| Hansaton | 050-6022-U4 | FDA UDI | Class II | Active |
| Hansaton | 075-5003 | FDA UDI | Class II | Active |
| Hansaton | 050-5703-U446 | FDA UDI | Class II | Active |
| Hansaton | 050-5624-U746 | FDA UDI | Class II | Active |
| Hansaton | 050-5742-U3 | FDA UDI | Class II | Active |
| Hansaton | 050-6001-U6 | FDA UDI | Class II | Active |
| Hansaton | 050-5704-U346 | FDA UDI | Class II | Active |
| Hansaton | 050-6085-U9 | FDA UDI | Class II | Active |
| Hansaton | 050-5711-U769 | FDA UDI | Class II | Active |
| Hansaton | 050-5693-U946 | FDA UDI | Class II | Active |
| Hansaton | 050-5858-U946 | FDA UDI | Class II | Active |
| Hansaton | 050-5990-U9 | FDA UDI | Class II | Active |
| Hansaton | 82519 | FDA UDI | Class II | Active |
| Hansaton | 050-5899-U3 | FDA UDI | Class II | Active |
| Hansaton | 050-6002-U7 | FDA UDI | Class II | Active |
| Hansaton | 050-5580-3546 | FDA UDI | Class II | Active |
| Hansaton | 050-6005-U7 | FDA UDI | Class II | Active |
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