Identity
- Trade Name
- Ponto 4, SIL EUDAMEDPonto FDA UDI
- Generic Name
- Anchored bone-conduction hearing implant system FDA UDI
- Device Name
- Ponto sound processor EUDAMEDPonto 4, silver FDA UDI
- Model / Reference
- 186779 EUDAMEDFDA UDI
- Description
- Ponto 4, silver FDA UDI
Identifiers
- Catalog Number
- 186779 FDA UDI
- Primary DI / UDI-DI
- 05712149025374 EUDAMEDFDA UDI
- Basic UDI-DI
- 57121491000182 EUDAMED
- FDA Product Code
- LXB FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Anchored bone-conduction hearing implant system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
MR Unsafe FDA UDI
Ponto 4, SIL by Oticon Medical AB — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190540 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 57121491000182 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (3)
- EUDAMED 8189309f-d03f-42cc-ba38-9fee0ce5343b 61 fields · synced Jul 10, 2026
- FDA UDI 897df65f-6012-4950-9905-1a88c56d027a 35 fields · synced May 29, 2026
- FDA 510(k) K190540 1 fields · synced May 18, 2026