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Chart(Distance): ESV3000™ and ESC2000™ - ETDRS 2000 Series - Sloan Letter Low Contrast - 10% Contrast - Chart 1 (6.5ft/2m)

by Good-Lite Company

Ref 500019-02, 500016-01, 500041, 500043, 500042Model Vision Acuity Testing and Screening Tests, Sets and Accessories

Active European Union

CE MDR

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/MDR Number++G211GGVATZM Basic UDI-DI Date28 Jul 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Trade Name
Chart(Distance): ESV3000™ and ESC2000™ - ETDRS 2000 Series - Sloan Letter Low Contrast - 10% Contrast - Chart 1 (6.5ft/2m)
Chart(Distance): ESV3000™ and ESC2000™ - ETDRS 2000 Series - Sloan Letter - Chart 1 (5ft/1.5m)
Chart(Distance): ESV3000™ and ESC2000™ - ETDRS 2000 Series - Sloan Letter - Chart 1 (6.5ft/2m)
Chart(Distance): ESV3000™ and ESC2000™ - ETDRS 2000 Series - Sloan Letter - Chart 3 (6.5ft/2m)
Chart(Distance): ESV3000™ and ESC2000™ - ETDRS 2000 Series - Sloan Letter - Chart 2 (6.5ft/2m)
Device Name
Vision Acuity Testing and Screening Tests, Sets and Accessories
Model / Reference
Vision Acuity Testing and Screening Tests, Sets and Accessories, 500019-02, 500016-01, 500041, 500043, 500042
Primary DI / UDI-DI
+G211500019-021T, +G211500016-011P, +G2115000411T, +G2115000431V, +G2115000421U
Basic UDI-DI
++G211GGVATZM
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008439
Authorised representative
Good-Lite B.V. NL-AR-000028608

Other devices from Good-Lite Company

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Properties

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