Identity
- Trade Name
- T1300 EUDAMED
- Device Name
- Tinnitus Masker EUDAMED
- Model / Reference
- Tinnitus masking device EUDAMED6945936705459 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945936705459 EUDAMED
- Basic UDI-DI
- 69459367xs005GB 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
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
T1300 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 | 69459367xs005GB | 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 156bd13b-7048-4fed-9d09-31be580f30b3 61 fields · synced Jul 9, 2026