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DIVE Automatic visual exam and screening

by Dive Medical S.l EUDAMED

Withdrawn No longer placed on the EU market

Ref DIVE Device for automatic visual exam and screening, DIVE Device for automatic visuale xam and screening, number : DIVE Device for automatic visual exam and screeningModel DIVE Device for automatic visual exam and screening

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437021711004DIVE01WF Basic UDI-DIDate16 May 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
DIVE Device for automatic visual exam and screening
Model / Reference
DIVE Device for automatic visual exam and screening, DIVE Device for automatic visuale xam and screening, number : DIVE Device for automatic visual exam and screening
Primary DI / UDI-DI
8437021711226, 8437021711202, 8437021711080, 8437021711103, 8437021711028, 8437021711066, 8437021711196, 8437021711233, 8437021711059, 8437021711097, 8437021711165, 8437021711110, 8437021711134, 8437021711240, 8437021711172, 8437021711219, 8437021711011, 8437021711189
Basic UDI-DI
8437021711004DIVE01WF
Direct Marketing DI
8437021711226
8437021711202
8437021711080
8437021711103
8437021711028
8437021711066
8437021711196
8437021711233
8437021711059
8437021711097
8437021711165
8437021711110
8437021711134
8437021711240
8437021711172
8437021711219
8437021711011
8437021711189
EMDN Code
Z1212012001 Visual functional assessment equipment
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001070

Properties

  • 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