Ha M-Core Sr 80 Blk Blkg
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- HA M-CORE SR 80 BLK BLKG EUDAMEDRexton FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- M-Core SR 80 Black-Black FDA UDI
- Model / Reference
- SLIM RIC EUDAMED10980561 EUDAMEDM-Core SR 80 FDA UDI
- Description
- M-Core SR 80 Black-Black FDA UDI
Identifiers
- Catalog Number
- 10980561 FDA UDI
- Primary DI / UDI-DI
- 04056839132241 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056839132241 EUDAMED
- FDA Product Code
- ESD 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 I FDA UDI
- Regulation Number
- 874.3300 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
Ha M-Core Sr 80 Blk Blkg by Sivantos GmbH — 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
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04056839132241 | 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
- Sivantos GmbH
- EUDAMED SRN
- DE-MF-000014326
Sources (2)
- EUDAMED a3522a96-dd6f-414b-a096-8c6110aa6c62 61 fields · synced Jun 19, 2026
- FDA UDI 915d42b2-7a78-49a5-b518-6e27b5a95440 35 fields · synced May 30, 2026