Identity
- Trade Name
- Cleartone I MCIC EUDAMED
- Device Name
- hearing aids EUDAMED
- Model / Reference
- ITE EUDAMED6945936716387 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945936716387 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
Cleartone I MCIC 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 |
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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 710196ad-e470-4a84-bf27-ce6b98e8050f 61 fields · synced Jul 31, 2026