Identity
- Device Name
- Otoscope EUDAMED
- Model / Reference
- PSN20002 EUDAMEDOtoscope EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974415288893 EUDAMED
- Basic UDI-DI
- 697441528oto4Y EUDAMED
- Direct Marketing DI
- 06974415288893 EUDAMED
- EMDN Code
- Z12149006 DIRECT OUTPATIENT 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
Otoscope by Zhejiang New Vision Imp & Exp 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 | 697441528oto4Y | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang New Vision Imp. & Exp. Co., Ltd
- EUDAMED SRN
- CN-MF-000048749
- Authorised Representative
- REP Europe GmbH DE-AR-000025090
Sources (1)
- EUDAMED cac4055b-36b2-4eae-b5f3-720d50060043 61 fields · synced Jul 19, 2026