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Philips
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 251753Model HI (ITE)Ref 251750Ref 251749Ref 251751
Identity
- Trade Name
- Philips EUDAMEDFDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- HEARLINK 1500 CIC FDA UDIHEARLINK 1700 CIC FDA UDIHEARLINK 1700 ITC FDA UDIHEARLINK 1700 IIC FDA UDI
- Model / Reference
- HI (ITE) EUDAMED251753 EUDAMEDFDA UDI251750 EUDAMEDFDA UDI251749 EUDAMEDFDA UDI251751 EUDAMEDFDA UDI
- Description
- HEARLINK 1500 CIC FDA UDIHEARLINK 1700 CIC FDA UDIHEARLINK 1700 ITC FDA UDIHEARLINK 1700 IIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464089055 EUDAMEDFDA UDI05714464089062 EUDAMEDFDA UDI05714464089048 EUDAMEDFDA UDI05714464089086 EUDAMEDFDA UDI
- Basic UDI-DI
- 57144640-HI-00084-RV EUDAMED
- FDA Product Code
- KLW FDA UDIOSM FDA UDI
- EMDN Code
- Y2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) EUDAMEDY2145060204 HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC) EUDAMEDY2145060202 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
- 874.3400 FDA UDI874.3305 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
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
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-00084-RV | 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 (8)
- EUDAMED a09693d4-231c-45dd-ace1-6e0c544ad85e 61 fields · synced Jul 25, 2026
- EUDAMED f0476c09-684b-4768-99d4-081abd88517e 61 fields · synced May 17, 2026
- EUDAMED cc271da7-f004-4711-a2cb-9721e61a5c4e 61 fields · synced May 17, 2026
- EUDAMED 2a4ebc98-0c28-4cdd-878e-b0721701abc7 61 fields · synced May 19, 2026
- FDA UDI df7f7d3e-2ad3-4c8b-99c7-a2b527ad9089 34 fields · synced May 30, 2026
- FDA UDI a97d336e-9866-428b-b09b-766c729cd742 34 fields · synced May 30, 2026
- FDA UDI 357b70b2-4708-43a5-8863-528629697140 34 fields · synced May 30, 2026
- FDA UDI 384bec07-b107-4548-9cdf-07a6f68e2e82 34 fields · synced May 30, 2026