Identity
- Trade Name
- Otoscope EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- OT-501, OT-503 EUDAMEDOT-501 EUDAMEDOT-503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976313750151 EUDAMED06976313750168 EUDAMED
- Basic UDI-DI
- 697631375OTXW4 EUDAMED
- Direct Marketing DI
- 06976313750151 EUDAMED06976313750168 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
Otoscope by AOJ HEALTH 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 | 697631375OTXW4 | Class I | Active |
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Manufacturer
- Manufacturer
- AOJ HEALTH Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000037449
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 03f6e3c2-01e8-4045-8dff-d9f247778164 61 fields · synced Jul 15, 2026
- EUDAMED e769e5bd-ab58-4f2d-a778-3a90268ad8fb 61 fields · synced May 18, 2026