Lewi R
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- LEWI R EUDAMEDlewi R Li EUDAMEDaudifon FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- audifon lewi R Li -- beige RITE FDA UDI
- Model / Reference
- Hearing aid EUDAMED039943-A110-313-1720 EUDAMED039943-A282-313-1720 EUDAMED039943-A110-9817-1720 EUDAMED039943-A110-311-1720 EUDAMEDlewi R Li FDA UDI
- Description
- audifon lewi R Li -- beige RITE FDA UDI
Identifiers
- Catalog Number
- 039943-A282-313-1720 FDA UDI
- Primary DI / UDI-DI
- +EADF039943A11031317201 EUDAMED+EADF039943A28231317201 EUDAMED+EADF039943A110981717201 EUDAMED+EADF039943A11031117201 EUDAMEDEADF039943A28231317201 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Air-conduction hearing aid, receiver-in-canal
Lewi R by audifon GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 (5)
- EUDAMED 58662a7d-d89e-4aba-9611-a4b4a222e216 61 fields · synced Jul 23, 2026
- EUDAMED 04b185e5-7a8e-47d3-a6b3-85bca54f0f7b 61 fields · synced May 16, 2026
- EUDAMED 952694ea-eeed-49ca-b6ba-4a6da1df2c99 61 fields · synced May 18, 2026
- EUDAMED 684750ce-be01-4f35-ae82-522c955413ad 61 fields · synced May 18, 2026
- FDA UDI 3a698047-ce19-4636-9441-755771384318 34 fields · synced May 29, 2026