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sueno pro R
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 025381-9507-3127-1720Model Noiser
Identity
- Trade Name
- sueno pro R EUDAMEDaudifon FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- RITE Tinnitus FDA UDI
- Model / Reference
- Noiser EUDAMED025381-9507-3127-1720 EUDAMEDsueno pro R FDA UDI
- Description
- RITE Tinnitus FDA UDI
Identifiers
- Catalog Number
- 025381-9507-3127-1720 FDA UDI
- Primary DI / UDI-DI
- D-025381-9507-3127-17202M EUDAMEDEADF0253819507312717201 FDA UDI
- Basic UDI-DI
- B-025381-9507-3127-17202M EUDAMED
- FDA Product Code
- KLW FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
sueno pro 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-025381-9507-3127-17202M | 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 45a53177-6c36-482b-9ee4-598282020116 61 fields · synced Jul 11, 2026
- FDA UDI 560b46ef-3768-40c2-8c48-1afb81b33e83 35 fields · synced May 29, 2026