Kit M-Core R-Li 80 Uk1 Sb
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- KIT M-CORE R-LI 80 UK1 SB EUDAMEDRexton FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- KIT M-CORE R-LI 80 UK1 SB FDA UDI
- Model / Reference
- RIC EUDAMED10980520 EUDAMEDKIT M-Core R-Li 80 FDA UDI
- Description
- KIT M-CORE R-LI 80 UK1 SB FDA UDI
Identifiers
- Catalog Number
- 10980520 FDA UDI
- Primary DI / UDI-DI
- 04056839122228 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056839122228 EUDAMED
- FDA Product Code
- OSM FDA UDIKLW 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 UDI874.3400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
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
No
Category: Air-conduction hearing aid, receiver-in-canal
Kit M-Core R-Li 80 Uk1 Sb by Sivantos GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056839122228 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sivantos GmbH
- EUDAMED SRN
- DE-MF-000014326
Sources (2)
- EUDAMED 3039453a-f8f3-472a-ba84-1dff81dd53ef 61 fields · synced Jun 20, 2026
- FDA UDI e992dba3-d17b-4725-bafb-7513eb36767a 35 fields · synced May 30, 2026