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Auto Kerato/Refractometer

by Ningbo Flo Optical Technology Development Co., Ltd. 4 variants

Ref FKR-710, CE-1, FR-8900, FKR-8900Model 710/8900/900

Active European Union

CE MDR CE MDD

Valid until

30 Jun 2031

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN26/00004742 Date30 Jun 2026IssuedStatusActive expires 30 Jun 2031
European UnionCE/MDD Number697542407167KP Basic UDI-DI Date25 Feb 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00004742 Active

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    30 Jun 2026
    Expires
    30 Jun 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Model / Reference
710/8900/900, FKR-710, CE-1, FR-8900, FKR-8900
Primary DI / UDI-DI
06975424071674, 06975424070080, 06975424072046, 06975424072923, 06975424070042, 06975424070035
Basic UDI-DI
697542407167KP, B-06975424070080, B-06975424070042, B-06975424070035
Direct Marketing DI
06975424071674
06975424072046
06975424072923
EMDN Code
Q0299 Ophthalmic devices - other
Device Class
Class IIa
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000008703
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Ningbo Flo Optical Technology Development 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