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Bioelectric amplifier

by metrovision SAS France EUDAMED

Ref HVM-AmpliModel Vision Monitor

EMDN Z12120180

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberBE26/00000270 Date17 Sep 2026IssuedStatusActive expires 17 Sep 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE26/00000270 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    17 Sep 2026
    Expires
    17 Sep 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Vision Monitor
Model / Reference
Vision Monitor, HVM-Ampli
Primary DI / UDI-DI
05060704130040
Basic UDI-DI
5060704130VM9K
Direct Marketing DI
05060704130040
EMDN Code
Z12120180 Ophtalmology assessments and diagnosis instruments - hardware accessories
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000002561

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    Class II

  • MonBabyBox

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  • MonBaby

    Class IIa

  • MonColor

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED debd5a81-f416-4aa7-a389-4edde926da94 61 fields · synced 24 Oct 2026