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Video otoscope

EUDAMED

Class I (EU MDR)

Ref NX-01Model VOT-01,VOT-02,VRN-01,VRN-02,NX-01,OT-BR001,OT-BR002,OT-BR003Ref OT-BR001Ref VRN-01Ref OT-BR002

by Shenzhen Besdata Technology Co., Ltd

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 EUDAMED
NX-01 EUDAMED
OT-BR001 EUDAMED
VRN-01 EUDAMED
OT-BR002 EUDAMED

Identifiers

Primary DI / UDI-DI
06971355351694 EUDAMED
06971355352592 EUDAMED
06971355350604 EUDAMED
06971355352608 EUDAMED
Basic UDI-DI
697135535058197 EUDAMED
EMDN Code
Z12021009 DIRECT OUTPATIENT VIDEO-OTOSCOPES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany EUDAMED
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

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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 (4)

  • EUDAMED 29ab3011-e70a-4b45-b090-5938b90a2410 61 fields · synced Jul 24, 2026
  • EUDAMED aa6974d9-6c9f-4bad-81dd-13bca400fa81 61 fields · synced May 17, 2026
  • EUDAMED ac46319e-b6fc-431d-884b-eebf25dec40b 61 fields · synced May 18, 2026
  • EUDAMED 8e3c7483-bf12-4da9-a021-0e863e6e12a6 61 fields · synced May 18, 2026