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sino R
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 023167-9039-313-1720Model Hearing aid
Identity
- Trade Name
- sino R EUDAMEDaudifon FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- RITE-TRT FDA UDI
- Model / Reference
- Hearing aid EUDAMED023167-9039-313-1720 EUDAMEDsino R FDA UDI
- Description
- RITE-TRT FDA UDI
Identifiers
- Catalog Number
- 023167-9039-313-1720 FDA UDI
- Primary DI / UDI-DI
- D-023167-9039-313-1720SU EUDAMEDEADF023167903931317201 FDA UDI
- Basic UDI-DI
- B-023167-9039-313-1720SU EUDAMED
- 510(k) Number
- K130514 FDA UDI
- FDA Product Code
- KLW FDA UDIESD FDA UDI
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, receiver-in-canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3400 FDA UDI874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
sino R by audifon GmbH & Co. KG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-023167-9039-313-1720SU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000008355
Sources (2)
- EUDAMED 3295dafa-50b2-4529-8906-6021020972ba 61 fields · synced Jun 19, 2026
- FDA UDI 2080e3aa-1ef2-48a8-91c5-428e2ed9cb70 35 fields · synced May 30, 2026