Skip to content

Randot Stereotest

by Essilor International

Ref SOO02

Randot Stereotest (SOO02) is a Class I device made by Essilor International, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 361502000000ISTEREOTESTVL), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number361502000000ISTEREOTESTVL Basic UDI-DI 03615020000809UDI-DIDate22 Oct 2026RegisteredStatusActive

Official records

  • EUDAMED public site Basic UDI-DI 361502000000ISTEREOTESTVL — open Devices and search for it

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  • Withdrawn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

Device name
Stereotest
Model / reference
SOO02
Primary DI / UDI-DI
03615020000809
Basic UDI-DI
361502000000ISTEREOTESTVL
EMDN code
Z1212012001 Visual functional assessment equipment
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000007175

Similar devices in this category

Other devices filed under VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT.

Other devices from Essilor International

See all devices from Essilor International →

Properties

Other properties (14, all answered No)