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VertiMobile

by Shanghai ZEHNIT Medical Technology Co., Ltd. China EUDAMED

Ref 001, 000, 001/ZT-VertiMobile-iPhone 7/8Model ZT-VertiMobile-iPhone 7/8, ZT-VertiMobile-iPhone 6/6s, ZT-VertiMobile-iPhone 7/8, ZT-VertiMobile-iPhone X/Xs, ZT-VertiMobile-iPhone 13/14/15

EMDN Z12140401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697272756ZTVM0257 Basic UDI-DIDate1 Dec 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Eye Movement Recording Goggles
Model / Reference
ZT-VertiMobile-iPhone 7/8, 001, ZT-VertiMobile-iPhone 6/6s, ZT-VertiMobile-iPhone X/Xs, ZT-VertiMobile-iPhone 13/14/15, 000, 001/ZT-VertiMobile-iPhone 7/8
Primary DI / UDI-DI
06972727560010, 06972727560003
Basic UDI-DI
697272756ZTVM0257, 697272756ZTVM0155
Direct Marketing DI
06972727560010
06972727560003
EMDN Code
Z12140401 Vestibular assessment systems
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000013234
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai ZEHNIT Medical Technology Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
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

Sources (3)

  • EUDAMED d476a34d-8017-4de1-8d0b-fe59be90c7f8 61 fields · synced 22 Oct 2026
  • EUDAMED 06972727560003|697272756ZTVM0155 61 fields · synced 18 May 2026
  • EUDAMED 06972727560010|697272756ZTVM0155 61 fields · synced 24 Oct 2026