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MonPackONE

by metrovision SAS France EUDAMEDGUDID

Ref HVM-MonPackONEModel Vision Monitor

Product code GWEEMDN Z12120103,Z12120111,Z1212012001,Z1212012002,Z1212012003,Z12120124,Z12120125

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberBE26/00000270 Date17 Sep 2026IssuedStatusActive expires 17 Sep 2031
United StatesGUDID listing GUDID Number05060704130019 UDI-DIDate1 Jul 2026ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

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 · GUDID · synced 22 Oct 2026

Trade Name
MonPackONE EUDAMED
Vision Monitor - MonPackONE GUDID
Generic Name
Electroretinograph
Model / Ref / Catalog
Vision Monitor, HVM-MonPackONE, 2026A
Primary DI / UDI-DI
05060704130019
Basic UDI-DI
5060704130VM9K
Direct Marketing DI
05060704130019
FDA Product Code
GWE, HLT, HLG, OUM, HOX
EMDN Code
Z12120103,Z12120111,Z1212012001,Z1212012002,Z1212012003,Z12120124,Z12120125
GMDN Term
Electroretinograph
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1890, 886.1640, 886.1700, 886.1050, 886.1150
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Vision Monitor
HVM-MonPackONE
GUDID
2026A
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000002561

Other devices from metrovision SAS

  • MonCv3

    Class IIa

  • Vision Monitor software

    Class IIa

  • MonCvONE

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 84b51f16-e781-490d-8269-36cc3488471d 61 fields · synced 22 Oct 2026
  • FDA UDI 93987839-18a3-4c95-91ac-f279a3cf3c08 34 fields · synced 22 Oct 2026