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Otoscope
EUDAMEDClass I (EU MDR)
Ref E005BGModel E005BG、E305BG、E004BG、E304BG、E003BGRef E304BGRef E003BG
Identity
- Trade Name
- Otoscope EUDAMED
- Device Name
- Otoscope EUDAMED
- Model / Reference
- E005BG、E305BG、E004BG、E304BG、E003BG EUDAMEDE005BG EUDAMEDE304BG EUDAMEDE003BG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975465800318 EUDAMED06975465800349 EUDAMED06975465800356 EUDAMED
- Basic UDI-DI
- 697546580OEBGRH EUDAMED
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Laryngoscope blade, reusable
Otoscope by Wuzhou Aokace 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 | 697546580OEBGRH | Class I | Active |
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Manufacturer
- Manufacturer
- Wuzhou Aokace Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027213
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 90e2bee5-a593-4e83-8d81-389001da03b8 61 fields · synced Jul 30, 2026
- EUDAMED dbbda5b2-6fa4-4622-840c-a3176b6c627b 61 fields · synced May 18, 2026
- EUDAMED a78cef32-4443-4531-8256-871fbe5f326c 61 fields · synced May 18, 2026