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Prosert®

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

Ref A1UL22,-10.0D, A1UL22, -10.0 DModel A1UL, AQBXL

Active European Union

CE MDR CE MDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-06952886887401 Basic UDI-DI 06952886887401UDI-DIDate31 Mar 2026RegisteredStatusActive
European UnionCE/MDD NumberB-06952886887401 Basic UDI-DI 06952886887401UDI-DIDate31 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  • Withdrawn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
A1UL22, -10.0D, A1UL, AQBXL, -10.0 D
Primary DI / UDI-DI
06952886887401
Basic UDI-DI
B-06952886887401, 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

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    Class IIb

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    Class IIb

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    Class IIb

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    Class IIb

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    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