Identity
- Trade Name
- Philips EUDAMEDFDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- HEARLINK 2030 ITC FDA UDI
- Model / Reference
- HI (ITE) EUDAMED245443 EUDAMEDFDA UDI
- Description
- HEARLINK 2030 ITC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464066377 EUDAMEDFDA UDI
- Basic UDI-DI
- 57144640-HI-00079-S7 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060202 HEARING AIDS IN-THE-CANAL (ITC) EUDAMED
- GMDN Term
- Air-conduction hearing aid, canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- 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 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 UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Philips by Sbo Hearing A/S — 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 | 57144640-HI-00079-S7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (2)
- EUDAMED 0804220f-9b15-4ddf-aa0b-ba66e77fc045 61 fields · synced May 30, 2026
- FDA UDI 2c71a9ad-75f5-469c-a346-689355615738 34 fields · synced May 30, 2026