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Primus-HD® Toric

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

Ref AT5UXL28,+31.5DModel ATUXL, ATBXL

Active European Union

CE MDR

Valid until

22 Sep 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 Number69528868B007SB Basic UDI-DI 06923669280405UDI-DIDate28 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Preloaded Intraocular Lens System
Model / reference
ATUXL, ATBXL, AT5UXL28, +31.5D
Primary DI / UDI-DI
06923669280405
Basic UDI-DI
69528868B007SB
EMDN code
P030102090301 IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC
Device class
Class IIb
EU registration type
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