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Otoscope
EUDAMEDClass I (EU MDR)
Ref OS811Model OS801, OS802, OS803, OS804, OS805, OS806, OS807, OS808, OS809, OS810, OS811, OS812, OS813, OS814, OS816, OS817, OS818, OS819, OS820, OS821, OS826, OS828, OS830
Identity
- Device Name
- Otoscope EUDAMED
- Model / Reference
- OS801, OS802, OS803, OS804, OS805, OS806, OS807, OS808, OS809, OS810, OS811, OS812, OS813, OS814, OS816, OS817, OS818, OS819, OS820, OS821, OS826, OS828, OS830 EUDAMEDOS811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971919461708 EUDAMED
- Basic UDI-DI
- 697191946EO4R EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Otoscope by Ningbo Albert Novosino Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697191946EO4R | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Albert Novosino Co., Ltd.
- EUDAMED SRN
- CN-MF-000008571
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 2fa8eb09-3ce7-46bb-8e5f-753b7c619b17 61 fields · synced Jul 8, 2026