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Prosert®

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

Ref A1UL22,+32.0DModel A1UL, AQBXL

Active European Union

CE MDR

Valid until

25 Feb 2030

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69528868B002RZ Basic UDI-DI 06952886888248UDI-DIDate4 Dec 2025RegisteredStatusActive

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  • Withdrawn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
A1UL, AQBXL, A1UL22, +32.0D
Primary DI / UDI-DI
06952886888248
Basic UDI-DI
69528868B002RZ
EMDN Code
P030102090201 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHOBIC ACRYLIC
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

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

Other devices from Eyebright Medical Technology (Beijing) Co., Ltd.

  • Intraocular Lens

    Class IIb

  • Prosert®

    Class IIb

  • Primus-HD® P

    Class IIb

  • Primus-HD® Yellow P

    Class IIb

  • Eye-Fold®

    Class IIb

  • Primus-HD®Yellow

    Class IIb

See all devices from Eyebright Medical Technology (Beijing) 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