Identity
- Trade Name
- Tactear 10 EUDAMED
- Device Name
- hearing aids EUDAMED
- Model / Reference
- ITE EUDAMED6945936704506 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945936704506 EUDAMED
- Basic UDI-DI
- 69459367xs003G7 EUDAMED
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Tactear 10 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 | 69459367xs003G7 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen NewSound Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000041673
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 3749f81a-b62b-4d2a-8b72-65c6f51f3558 61 fields · synced Jul 9, 2026