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EyeCee ONE crystal preloaded

by NIDEK.CO.Ltd., 10 variants

Ref NP-1/NP-1C/Aktis SP_B01 E001Model NP-1

Active European Union

CE MDR

Valid until

13 Dec 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

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/MDR Number4202074CE04 Date30 Oct 2025IssuedStatusExpired expired 1 Nov 2026

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 4202074TD01 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    30 Oct 2025
    Expires
    13 Dec 2028
    Reason
    Add device or group
  • 4202074CE04 Expired

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    30 Oct 2025
    Expires
    1 Nov 2026
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
EyeCee ONE preloaded
Model / Reference
NP-1, NP-1/NP-1C/Aktis SP_B01 E001
Primary DI / UDI-DI
04987669317082
Basic UDI-DI
4987669227GL
EMDN Code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000040151
Authorised representative
NIDEK SA FR-AR-000000341

Other devices from Nidek Co., Ltd.

  • NexLoad NP Toric

    Class IIb

  • NexLoad NP

    Class IIb

  • EyeCee ONE crystal preloaded

    Class IIb

  • EyeCee ONE preloaded

    Class IIb

  • P030102090301

    Class IIb

  • NexLoad NP Clear

    Class IIb

See all devices from Nidek Co., Ltd. →

Properties

  • Sterile
  • Implantable

Other properties (12)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No