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MonCvONE

by metrovision SAS France EUDAMED510(k)GUDID

Ref HVM-MonCvONEModel Vision Monitor510(k) K212936

Product code GWEEMDN Z12120103,Z1212012001,Z1212012002,Z1212012003,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 Number05060704130002 UDI-DIDate1 Jul 2026ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK212936 Date21 Nov 2022ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

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 · 510(k) · GUDID · synced 22 Oct 2026

Trade Name
MonCvONE EUDAMED
Vision Monitor - MonCvONE GUDID
Generic Name
Electroretinograph
Model / Ref / Catalog
Vision Monitor, HVM-MonCvONE, 2026A
Primary DI / UDI-DI
05060704130002
Basic UDI-DI
5060704130VM9K
Direct Marketing DI
05060704130002
FDA Product Code
GWE, HLT, HPT, HLG, OUM
EMDN Code
Z12120103,Z1212012001,Z1212012002,Z1212012003,Z12120125
GMDN Term
Electroretinograph
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1890, 886.1640, 886.1605, 886.1700, 886.1050
Market of Registration
France
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

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

Manufacturer details

EUDAMED SRN
FR-MF-000002561
FDA applicant
Metrovision

Other devices from metrovision SAS

  • MonPackONE

    Class IIa

  • MonCv3

    Class IIa

  • Vision Monitor software

    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 (3)

  • EUDAMED 4bf1a7eb-22cf-48bc-9517-dced609e448b 85 fields · synced 22 Oct 2026
  • FDA UDI f5ef670f-555c-43ec-aa2d-e5b59e7a72ed 34 fields · synced 22 Oct 2026
  • FDA 510(k) K212936 1 fields · synced 18 May 2026