Identity
- Trade Name
- NewsoundFit6 EUDAMED
- Device Name
- NewsoundFit6 EUDAMED
- Model / Reference
- Software EUDAMED6945936705404 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945936705404 EUDAMED
- Basic UDI-DI
- 69459367xs004G9 EUDAMED
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NewsoundFit6 by Xiamen NewSound Technology Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69459367xs004G9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen NewSound Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000041673
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 8951ac48-763d-48cd-af29-d7a2f8ff63bd 61 fields · synced Oct 6, 2026