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Toric Intraocular Lens

by Henan Simedice Biotechnologies Co., Ltd. 363 variants

Ref ST10Model ST1, ST2, ST3, ST4, ST5, ST6, ST7, ST8, ST9,ST10

Active European Union

CE MDR

Valid until

1 Dec 2029

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 Number697420025P030102090301VC Basic UDI-DI Date10 Mar 2026RegisteredStatusActive

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6128787TD02 Active

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Jun 2025
    Expires
    1 Jun 2030
  • 6128787CE01 Active Supplemented

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 Jan 2026
    Expires
    1 Dec 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Toric Intraocular Lens
Model / Reference
ST1, ST2, ST3, ST4, ST5, ST6, ST7, ST8, ST9, ST10
Primary DI / UDI-DI
06974200254492, 06974200254362, 06974200254171, 06974200254454, 06974200254416, 06974200254386, 06974200254164, 06974200254324, 06974200254270, 06974200254348, 06974200254225, 06974200254249, 06974200254294, 06974200254201, 06974200254423, 06974200254188, 06974200254287, 06974200254478, 06974200254102, 06974200254379, 06974200254331, 06974200254157, 06974200254508, 06974200254430, 06974200254485, 06974200254256, 06974200254300, 06974200254133, 06974200254447, 06974200254232, 06974200254218, 06974200254355, 06974200254126, 06974200254409, 06974200254393, 06974200254195, 06974200254461, 06974200254317
Basic UDI-DI
697420025P030102090301VC
Direct Marketing DI
06974200254492
06974200254362
06974200254171
06974200254454
06974200254416
06974200254386
06974200254164
06974200254324
06974200254270
06974200254348
06974200254225
06974200254249
06974200254294
06974200254201
06974200254423
06974200254188
06974200254287
06974200254478
06974200254102
06974200254379
06974200254331
06974200254157
06974200254508
06974200254430
06974200254485
06974200254256
06974200254300
06974200254133
06974200254447
06974200254232
06974200254218
06974200254355
06974200254126
06974200254409
06974200254393
06974200254195
06974200254461
06974200254317
EMDN Code
P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000017957
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Other devices from Henan Simedice Biotechnologies Co., Ltd.

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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