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Neutral
EUDAMEDFDA UDIClass I (EU MDR)
Ref 226293Model Hearing instrument chargerRef 278397Ref 285025Model OneAppRef 286065Model Fitting SoftwareRef 286080Ref 286081Ref 284518Ref 285024Ref 225684Ref 255714Ref 228195Model Remote Control App
Identity
- Trade Name
- Neutral EUDAMEDFDA UDI
- Generic Name
- Noninvasive device battery charger FDA UDIHearing aid/implant system remote control FDA UDI
- Device Name
- CHARGER PLUS, MNB T R FDA UDIREMOTELINK 2.5.0 IOS FDA UDI
- Model / Reference
- Hearing instrument charger EUDAMED226293 EUDAMEDFDA UDI278397 EUDAMEDOneApp EUDAMED285025 EUDAMEDFitting Software EUDAMED286065 EUDAMED286080 EUDAMED286081 EUDAMED284518 EUDAMED285024 EUDAMED225684 EUDAMED255714 EUDAMEDRemote Control App EUDAMED228195 EUDAMEDFDA UDI
- Description
- CHARGER PLUS, MNB T R FDA UDIREMOTELINK 2.5.0 IOS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464032846 EUDAMEDFDA UDI05714464150687 EUDAMED05714464168088 EUDAMED05714464175406 EUDAMED05714464175550 EUDAMED05714464175567 EUDAMED05714464166817 EUDAMED05714464168071 EUDAMED05714464012664 EUDAMED05714464099412 EUDAMED05714464012794 EUDAMEDFDA UDI
- Basic UDI-DI
- 57144640-HICHAR-00065-X7 EUDAMED57144640-HICHAR-00094-XK EUDAMED57144640-ONEAPP-00086-KM EUDAMED57144640-fSW-000012-28 EUDAMED57144640-ONEAPP-00085-KJ EUDAMED57144640-HICHAR-00100-VZ EUDAMED57144640-RCAPP-00005-A3 EUDAMED
- FDA Product Code
- KLW FDA UDIOSM FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMEDY214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Noninvasive device battery charger FDA UDIHearing aid/implant system remote control FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3400 FDA UDI874.3305 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark 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
No
FDA UDIFDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Neutral by Sbo Hearing A/S — Class I — 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 | 57144640-HICHAR-00065-X7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (14)
- EUDAMED 61303adf-170a-4eb0-abcc-d629405de0ab 61 fields · synced Sep 30, 2026
- EUDAMED 564975d0-1ad9-4fd8-b1f0-0e84b17cb0e6 61 fields · synced May 17, 2026
- EUDAMED 4c03b358-bc9c-4c49-a531-4bd4bddf99fb 61 fields · synced May 17, 2026
- EUDAMED 29e13c3e-1f9b-446b-9888-1945f94dab60 61 fields · synced May 17, 2026
- EUDAMED 1ff17e90-e6a0-4917-a02a-b49357e07397 61 fields · synced May 17, 2026
- EUDAMED 854185b0-1e9c-4d23-ad1b-0fe39ab61d1a 61 fields · synced May 18, 2026
- EUDAMED 2cb9a6d7-bbd3-4eaa-a3d5-8b974b2cc9d3 61 fields · synced May 18, 2026
- EUDAMED e242fec4-3a2e-42ce-bde5-ada370e69253 61 fields · synced May 18, 2026
- EUDAMED 32779d2f-ae6c-40a9-b601-49101cd9eb5d 61 fields · synced May 18, 2026
- EUDAMED f9adfdc7-0aa8-4935-af21-7ee90d9ed1a5 61 fields · synced May 19, 2026
- EUDAMED 4c6ca140-54c6-49d1-be22-bb2cf821cf67 61 fields · synced May 19, 2026
- FDA UDI 75ca9e89-57ee-4892-86f0-062c04d8414c 34 fields · synced May 30, 2026
- FDA UDI 93f701f2-9f5c-48ab-bef4-ef98dc79fc38 34 fields · synced May 30, 2026
- EUDAMED 8c1eeea4-fd7d-4e0e-8d55-7629639e76e0 61 fields · synced Sep 30, 2026