Ha Ampli-Energy R 4mc Blk
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- HA AMPLI-ENERGY R 4MC BLK EUDAMEDAMPLIFON FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- HA AMPLI-ENERGY R 4MC BLK FDA UDI
- Model / Reference
- RIC EUDAMED10974265 EUDAMEDampli-energy R 4MC FDA UDI
- Description
- HA AMPLI-ENERGY R 4MC BLK FDA UDI
Identifiers
- Catalog Number
- 10974265 FDA UDI
- Primary DI / UDI-DI
- 04056839116135 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04056839116135 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, behind-the-ear 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
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 Ampli-Energy R 4mc Blk 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-04056839116135 | 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 f187f084-a0a3-4434-ad73-f10acda1ba8f 61 fields · synced Jun 19, 2026
- FDA UDI b4d03441-c3e0-4dd9-81c5-ba6c2aab3140 35 fields · synced May 25, 2026