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ArgusClarityTM

by Suzhou MicroPort Argus Medical Corp.

Ref Insight-100

Active European Union

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971231030231 Basic UDI-DI 06971231030231UDI-DIDate5 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
ArgusClarityTM Optical Coherence Tomography Imaging System
Model / Reference
Insight-100
Primary DI / UDI-DI
06971231030231
Basic UDI-DI
B-06971231030231
EMDN Code
Z12040101 Algesimeters
Device Class
Class IIb
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000027422
Authorised representative
MicroPort Medical B.V. NL-AR-000000166

Other devices from Suzhou MicroPort Argus Medical Corp

  • ArgusScout®

    Class III

Properties

  • Reusable
  • Measuring Function

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No