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Ear wax Removal Tool Camera
EUDAMEDClass I (EU MDR)
Ref EWR-10Model EWR-10, EWR-50Ref EWR-50
Identity
- Trade Name
- Ear wax Removal Tool Camera EUDAMED
- Device Name
- Ear Wax Removal Tool Camera EUDAMED
- Model / Reference
- EWR-10, EWR-50 EUDAMEDEWR-10 EUDAMEDEWR-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976313750731 EUDAMED06976313751530 EUDAMED
- Basic UDI-DI
- 697631375GIMAEWR-10FC EUDAMED
- Direct Marketing DI
- 06976313750731 EUDAMED06976313751530 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
Ear wax Removal Tool Camera by AOJ HEALTH Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697631375GIMAEWR-10FC | 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 f6d92865-92c6-4d55-b943-b35344f7d1b5 61 fields · synced Jul 11, 2026
- EUDAMED 15496918-61dc-464a-90cc-e5ca866a19cc 61 fields · synced May 17, 2026