← Back to catalogue
ENT-HubNex(One-Stop Visualization System for ENT)
EUDAMEDClass I (EU MDR)
Ref OT-BR001,OT-BR002,OT-BR003(Video Otoscope); SE-BR001(Sinuscope); MIP-B0124(Image Processor); MET-BR001(Trolley)
Identity
- Trade Name
- ENT-HubNex(One-Stop Visualization System for ENT) EUDAMED
- Device Name
- ENT-HubNex(One-Stop Visualization System for ENT) EUDAMED
- Model / Reference
- OT-BR001,OT-BR002,OT-BR003(Video Otoscope); SE-BR001(Sinuscope); MIP-B0124(Image Processor); MET-BR001(Trolley) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355352646 EUDAMED
- Basic UDI-DI
- 69713553526399T EUDAMED
- EMDN Code
- Z12021099 ENT ENDOSCOPY INSTRUMENTS - OTHER 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
ENT-HubNex(One-Stop Visualization System for ENT) 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 | 69713553526399T | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Besdata Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018921
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED b284f757-28a9-458d-ae6c-e02654fd4672 61 fields · synced Jul 23, 2026
- EUDAMED b284f757-28a9-458d-ae6c-e02654fd4672-1 61 fields · synced Jun 10, 2026