← Back to catalogue
risa R
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 030240-9809-9817-1720Model Hearing aid
Identity
- Trade Name
- risa R EUDAMEDaudifon FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- audifon risa R -- silbergrau RITE FDA UDI
- Model / Reference
- Hearing aid EUDAMED030240-9809-9817-1720 EUDAMEDrisa R FDA UDI
- Description
- audifon risa R -- silbergrau RITE FDA UDI
Identifiers
- Catalog Number
- 030240-9809-9817-1720 FDA UDI
- Primary DI / UDI-DI
- D-030240-9809-9817-1720V3 EUDAMEDEADF0302409809981717201 FDA UDI
- Basic UDI-DI
- B-030240-9809-9817-1720V3 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
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
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
Category: Air-conduction hearing aid, receiver-in-canal
risa R by audifon GmbH & Co. KG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, receiver-in-canal.
- SET CROS PURE CHARGE&GO PRL — Signia GmbH · Class IIa
- HA EVK E-FS-T USA 440 SLVGR — Widex A/S · Class IIa
- AGXO — Sbo Hearing A/S · Class IIa
- SoniTon UP6 312 trial — Sonova AG · Class IIa
- HA VIO E156 T BC LI GPH — WSAUD A/S · Class IIa
- HANSATON — Hansaton Akustik GmbH · Class II
- PHONAK — Sonova AG · Class II
- AMPLIFON — Starkey Laboratories Inc. · Class II
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-030240-9809-9817-1720V3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- audifon GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000008355
Sources (2)
- EUDAMED 8b0ff3ff-2898-4d36-ab07-d6f226c4536e 61 fields · synced Jun 18, 2026
- FDA UDI 742a87a8-0042-4c44-b5e8-564e90b016cd 34 fields · synced May 29, 2026