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Video Otoscope
EUDAMEDClass I (EU MDR)
Ref V0S1-02Model VOS1-01, VOS1-02Ref VOS1-01
Identity
- Trade Name
- Video Otoscope EUDAMED
- Device Name
- Video Otoscope EUDAMED
- Model / Reference
- VOS1-01, VOS1-02 EUDAMEDV0S1-02 EUDAMEDVOS1-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937048211065 EUDAMED06937048211058 EUDAMED
- Basic UDI-DI
- 697028348UE000016JC EUDAMED
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Video Otoscope by Zhejiang UE Medical Corp. — 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 | 697028348UE000016JC | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang UE Medical Corp.
- EUDAMED SRN
- CN-MF-000003020
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 37c6e7db-4179-4f3c-a2c9-e1192f210125 61 fields · synced Aug 1, 2026
- EUDAMED 761bae03-d04e-4811-996b-70c6154ddaa4 61 fields · synced May 17, 2026