Identity
- Trade Name
- audibene Ear, Nose & Throat Smart Otoscope EUDAMED
- Device Name
- Ear, Nose & Throat Smart Otoscope EUDAMED
- Model / Reference
- NTE430 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976580000119 EUDAMED
- Basic UDI-DI
- 697658000200397076Q2 EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Otoscope, endoscopic
audibene Ear, Nose & Throat Smart Otoscope by Dongguan HEMS Electronic Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Otoscope, endoscopic.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697658000200397076Q2 | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan HEMS Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000042670
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 0ac58319-06c3-4e32-a0a3-a698c893223a 61 fields · synced Jul 14, 2026