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Solix Essential

by Optovue, Inc.

Ref Solix Essential

Solix Essential is a Class IIa device made by Optovue, Inc., registered in EUDAMED on 11 May 2026 (Basic UDI-DI 08588480068037K), active as of 24 Oct 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08588480068037K Basic UDI-DI 00858848006261UDI-DIDate11 May 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Solix
Model / reference
Solix Essential
Primary DI / UDI-DI
00858848006261
Basic UDI-DI
08588480068037K
Direct marketing DI
00858848006261
EMDN code
Z12120121 Optical consistency tomographs
Device class
Class IIa
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000018369
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under OPTICAL CONSISTENCY TOMOGRAPHS.

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See all devices from Optovue, Inc. →

Properties

  • Measuring function
Other properties (13, all answered No)