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sino ITE V50
EUDAMEDClass IIa (EU MDR)
Ref 023297-9259-327-357Model Hearing aidRef 023297-9259-334-357Ref 023297-9259-327-358Ref 023297-9259-315-357Ref 023297-9259-334-358Ref 023297-9259-315-358
Identity
- Trade Name
- sino ITE V50 EUDAMED
- Model / Reference
- Hearing aid EUDAMED023297-9259-327-357 EUDAMED023297-9259-334-357 EUDAMED023297-9259-327-358 EUDAMED023297-9259-315-357 EUDAMED023297-9259-334-358 EUDAMED023297-9259-315-358 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-023297-9259-327-35746 EUDAMEDD-023297-9259-334-3573J EUDAMEDD-023297-9259-327-35848 EUDAMEDD-023297-9259-315-35733 EUDAMEDD-023297-9259-334-3583L EUDAMEDD-023297-9259-315-35835 EUDAMED
- Basic UDI-DI
- B-023297-9259-327-35746 EUDAMEDB-023297-9259-334-3573J EUDAMEDB-023297-9259-327-35848 EUDAMEDB-023297-9259-315-35733 EUDAMEDB-023297-9259-334-3583L EUDAMEDB-023297-9259-315-35835 EUDAMED
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) 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
sino ITE V50 by audifon GmbH & Co. KG — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-023297-9259-327-35746 | Class IIa | Active |
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Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000008355
Sources (6)
- EUDAMED 532364c5-3c22-42cc-b32f-85a849207829 61 fields · synced Oct 6, 2026
- EUDAMED 14f047e0-327d-4125-a2c9-b1a202ade153 61 fields · synced May 17, 2026
- EUDAMED 314e2b58-7903-47d5-bfbb-127431c934ed 61 fields · synced May 18, 2026
- EUDAMED a4c02885-d689-46a1-b29a-723f184972a1 61 fields · synced May 19, 2026
- EUDAMED 1aedc276-aac5-4d29-92ad-00c6170784d5 61 fields · synced May 19, 2026
- EUDAMED 4dadb58e-9c24-43e8-9e4a-d52a796ec31f 61 fields · synced May 19, 2026