Identity
- Trade Name
- Ponto 5 SuperPower, CNB EUDAMEDPonto FDA UDI
- Generic Name
- Bone-conduction hearing implant system sound processor/vibrator FDA UDI
- Device Name
- Ponto sound processor EUDAMEDPONTO 5 SUPERPOWER, CNB FDA UDI
- Model / Reference
- 223164 EUDAMEDFDA UDI
- Description
- PONTO 5 SUPERPOWER, CNB FDA UDI
Identifiers
- Catalog Number
- 223164 FDA UDI
- Primary DI / UDI-DI
- 05712149026524 EUDAMEDFDA UDI
- Basic UDI-DI
- 57121491000182 EUDAMED
- FDA Product Code
- MAH FDA UDILXB FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Bone-conduction hearing implant system sound processor/vibrator 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 5 SuperPower, CNB by Oticon Medical AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57121491000182 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (2)
- EUDAMED c04907eb-29d1-4763-b939-320279fa17ba 61 fields · synced Jul 18, 2026
- FDA UDI 300c4098-df61-417a-8ade-1dabbddf56e9 35 fields · synced May 29, 2026