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risa R Li
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 039945-A286-3159-1720Model Hearing aid
Identity
- Trade Name
- risa R Li EUDAMEDaudifon FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- audifon risa R Li -- graphit RITE FDA UDI
- Model / Reference
- Hearing aid EUDAMED039945-A286-3159-1720 EUDAMEDrisa R Li FDA UDI
- Description
- audifon risa R Li -- graphit RITE FDA UDI
Identifiers
- Catalog Number
- 039945-A286-3159-1720 FDA UDI
- Primary DI / UDI-DI
- +EADF039945A286315917201 EUDAMEDEADF039945A286315917201 FDA UDI
- Basic UDI-DI
- ++EADFa20HNPM EUDAMED
- FDA Product Code
- OSM 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
- 874.3305 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
risa R Li by audifon GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EADFa20HNPM | 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 94c88bff-f2ae-4146-819c-8eef73ad25a0 61 fields · synced Jun 17, 2026
- FDA UDI 813425cb-35e6-4798-af9a-07e986ffda64 34 fields · synced May 30, 2026