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HVM Home Vision Monitor

by Vital Art and Science, LLC

Ref Model 0005 HVM Home Vision Monitor App

Active European Union

CE MDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-US-MF-000028600U5 Basic UDI-DI D-US-MF-000028600U5UDI-DIDate27 Sep 2022RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Home Vision Monitor App
Model / Reference
Model 0005 HVM Home Vision Monitor App
Primary DI / UDI-DI
D-US-MF-000028600U5
Basic UDI-DI
B-US-MF-000028600U5
EMDN Code
Z1212012092 Instruments for the assessment of visual functionality - medical device software
Device Class
Class I
Special Device Type
-1192
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000028600
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties

Other properties (11)

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