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Microclear

by Suzhou Microclear Medical Instruments Co., Ltd 40 variants

Ref OCT PLUS-3+CRO SEModel ACRO models (12) , AOCT models (24)

Active European Union

CE MDR

Valid until

20 May 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN25/00003315 Date28 Jul 2026IssuedStatusActive expires 20 May 2030

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN25/00003315 Active Amended

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    28 Jul 2026
    Expires
    20 May 2030
    Reason
    Mnf data change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Ophthalmic Laser Diagnosis Device
Model / Reference
ACRO models (12), AOCT models (24), OCT PLUS-3+CRO SE
Primary DI / UDI-DI
06970990160852
Basic UDI-DI
697099016OLDDPZ
Direct Marketing DI
06970990160852
EMDN Code
Z12120199 Ophtalmology assessments and diagnosis instruments – other
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014411
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Suzhou Microclear Medical Instruments Co., Ltd.

See all devices from Suzhou Microclear Medical Instruments Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No