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Video otoscope
EUDAMEDClass I (EU MDR)
Ref OT-BR003Model VOT-01,VOT-02,VRN-01,VRN-02,NX-01,OT-BR001,OT-BR002,OT-BR003
Identity
- Trade Name
- Video otoscope EUDAMED
- Device Name
- Video otoscope EUDAMED
- Model / Reference
- VOT-01,VOT-02,VRN-01,VRN-02,NX-01,OT-BR001,OT-BR002,OT-BR003 EUDAMEDOT-BR003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355352615 EUDAMED
- Basic UDI-DI
- 697135535058197 EUDAMED
- EMDN Code
- Z12021009 DIRECT OUTPATIENT VIDEO-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
Video otoscope by Shenzhen Besdata Technology 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 | 697135535058197 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Besdata Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018921
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 8eab99c8-245a-432b-96c1-a9ee9f5ec1e2 61 fields · synced Jun 19, 2026