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Hector

by Munich Surgical Imaging GmbH EUDAMED

Active European Union

Ref V12406-01Model V12400-01

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000328309 Date14 Oct 2026IssuedStatusActive expires 22 Apr 2031

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000328309 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    14 Oct 2026
    Expires
    22 Apr 2031
    Reason
    Add device or group

Specification

EUDAMED

Device Name
iOCT Module
Model / Reference
V12400-01, V12406-01
Primary DI / UDI-DI
04064434000261
Basic UDI-DI
4064434SeeLumaiOCTBT
Direct Marketing DI
04064434000261
EMDN Code
Z12120121 Optical consistency tomographs
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000009644

Other devices from Munich Surgical Imaging GmbH

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