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Max Vision®Toric

by Eyebright Medical Technology (Beijing) Co., Ltd. 1,000+ variants

Ref AM4T4UXL24,-7.5DModel AMTUXL

Active European Union

CE MDR CE MDD

Valid until

25 Aug 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06941264928881 Basic UDI-DI 06941264928881UDI-DIDate27 Mar 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06941264928881 Basic UDI-DI 06941264928881UDI-DIDate27 Mar 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Device name
Preloaded Intraocular Lens System
Model / reference
AM4T4UXL24, -7.5D, AMTUXL
Primary DI / UDI-DI
06941264928881
Basic UDI-DI
B-06941264928881, 69528868B015SA
EMDN code
P030102100301 IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device class
Class IIb
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000003041
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Supplied sterile
  • Implantable

Other properties (13)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Sutures: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No