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He-M
EUDAMEDClass IIa (EU MDR)
Ref 021958-002-9736-358Model Receiver unitRef 021958-002-8431-358Ref 021958-220-9736-358Ref 021958-002-8432-358Ref 021958-002-8432-357Ref 021958-002-8430-358Ref 021958-002-8431-357Ref 021958-220-8430-357
Identity
- Trade Name
- HE-M EUDAMED
- Model / Reference
- Receiver unit EUDAMED021958-002-9736-358 EUDAMED021958-002-8431-358 EUDAMED021958-220-9736-358 EUDAMED021958-002-8432-358 EUDAMED021958-002-8432-357 EUDAMED021958-002-8430-358 EUDAMED021958-002-8431-357 EUDAMED021958-220-8430-357 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-021958-002-9736-358R5 EUDAMEDD-021958-002-8431-358M8 EUDAMEDD-021958-220-9736-358TK EUDAMEDD-021958-002-8432-358MK EUDAMEDD-021958-002-8432-357MH EUDAMEDD-021958-002-8430-358LV EUDAMEDD-021958-002-8431-357M6 EUDAMEDD-021958-220-8430-357P9 EUDAMED
- Basic UDI-DI
- B-021958-002-9736-358R5 EUDAMEDB-021958-002-8431-358M8 EUDAMEDB-021958-220-9736-358TK EUDAMEDB-021958-002-8432-358MK EUDAMEDB-021958-002-8432-357MH EUDAMEDB-021958-002-8430-358LV EUDAMEDB-021958-002-8431-357M6 EUDAMEDB-021958-220-8430-357P9 EUDAMED
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The HE-M device is a high-fidelity transcutaneous endocrine disruptor (ENDOCRINE_DISRUPTOR) that uses transdermal delivery of a proprietary hormone replacement therapy (HRT) to stimulate natural endogenous hormones, potentially aiding in the treatment and management of conditions such as low testosterone levels. This advanced medical device is designed for professional use only.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-021958-002-9736-358R5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000008355
Sources (8)
- EUDAMED 5bb5793b-5f8e-4187-8d53-83550a007619 61 fields · synced Oct 6, 2026
- EUDAMED 630cbec8-5fd3-4c60-9395-a44b62153b41 61 fields · synced May 17, 2026
- EUDAMED c63b507c-3274-41c7-8093-ab73394af801 61 fields · synced May 17, 2026
- EUDAMED 03792d0c-e9bf-4375-bff8-daf032474906 61 fields · synced May 17, 2026
- EUDAMED 28a0231e-4f22-4d85-b1ed-4aaf9eb407ef 61 fields · synced May 18, 2026
- EUDAMED 3c5359da-b287-4073-8ea7-c3c644fd9fb8 61 fields · synced May 18, 2026
- EUDAMED b98d1caa-36df-4e44-b5f3-2e3e0005fde5 61 fields · synced May 18, 2026
- EUDAMED 03ac232e-db58-4ea1-9166-b808638e8d1e 61 fields · synced May 19, 2026