Identity
- Trade Name
- Herz Medical Instruments Hearing Aids EUDAMED
- Device Name
- Hearing Aids EUDAMED
- Model / Reference
- JH-351 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971094537618 EUDAMED
- Basic UDI-DI
- B-06971094537618 EUDAMED
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Herz Medical Instruments Hearing Aids by Huizhou Jinghao Medical Technology Co., Ltd — Class IIa — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971094537618 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Huizhou Jinghao Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000020483
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 1ea5b302-42d9-42d2-96da-f482859448ab 61 fields · synced Oct 7, 2026