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Electronic Nasopharyngolaryngoscope Image-assisted Monitoring Software

by Shanghai EndoVista Information Technology Co., Ltd.

Ref /Model EV ENT-100

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69775504401YM Basic UDI-DI 06977550440003UDI-DIDate10 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Electronic Nasopharyngolaryngoscope Image-assisted Monitoring Software
Model / Reference
EV ENT-100, /
Primary DI / UDI-DI
06977550440003
Basic UDI-DI
69775504401YM
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class I
Special Device Type
Software
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000052086
Authorised representative
Everbiz GmbH DE-AR-000008964

Other devices from Shanghai EndoVista Information Technology Co., Ltd.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No