Identity
- Trade Name
- Hearing aids EUDAMEDCeretone FDA UDI
- Generic Name
- Air-conduction hearing aid, in-the-ear FDA UDI
- Device Name
- Hearing aids (Digital) EUDAMEDOTC Hearing Aid FDA UDI
- Model / Reference
- CE-A80 EUDAMEDCore one FDA UDI
- Description
- OTC Hearing Aid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010331095 EUDAMEDFDA UDI
- Basic UDI-DI
- 697109453DigitalV2 EUDAMED
- FDA Product Code
- QUF FDA UDI
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, in-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hearing aids by Huizhou Jinghao Medical Technology Co., Ltd — 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 | 697109453DigitalV2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huizhou Jinghao Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000020483
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 66fe79e6-99cb-4fe8-9d2a-b7aeb99a401a 61 fields · synced Oct 6, 2026
- FDA UDI 8688f930-d230-4c10-a808-a5ed488beeb2 33 fields · synced May 25, 2026