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EarQ
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 229878Model HI (BTE)Ref 235838Ref 229876
Identity
- Trade Name
- EarQ EUDAMEDFDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- EARQ F40 MINIBTE R C063 FDA UDI
- Model / Reference
- HI (BTE) EUDAMED229878 EUDAMED235838 EUDAMEDFDA UDI229876 EUDAMED
- Description
- EARQ F40 MINIBTE R C063 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464023127 EUDAMED05714464045181 EUDAMEDFDA UDI05714464023103 EUDAMED
- Basic UDI-DI
- 57144640-HI-000014-WQ EUDAMED57144640-HI-00052-R8 EUDAMED
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMEDY2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3400 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
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
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
Category: Air-conduction hearing aid, receiver-in-canal
EarQ by Sbo Hearing A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-000014-WQ | 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 (4)
- EUDAMED 8800a1fe-55df-49e3-86b3-e6ed67fe0728 61 fields · synced Jul 31, 2026
- EUDAMED ec23f077-340e-46f8-840a-c80cfb201f87 61 fields · synced May 17, 2026
- EUDAMED d5ed6222-4d4f-4ce8-bd10-bb5714ad1d1b 61 fields · synced May 18, 2026
- FDA UDI aa08c845-c45f-4cee-bb04-6a29a4b217cb 34 fields · synced May 30, 2026