Skip to content

Aspira-aA+ SL 00.0

by HumanOptics Holding AG

Ref 00086450

Active European Union

CE MDR

Valid until

12 Jun 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier TÜV NORD CERT GmbH

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 Number44911221836 Date10 Jun 2026IssuedStatusActive expires 12 Jun 2030

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 44911221836 Active Supplemented

    Quality management system EU MDR

    Certifier
    TÜV NORD CERT GmbH 0044
    Issued
    10 Jun 2026
    Expires
    12 Jun 2030
    Reason
    Other
  • 44912221836 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV NORD CERT GmbH 0044
    Issued
    10 Jun 2026
    Expires
    12 Jun 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Aspira-aA+ SL 00.0
Aspira-aA+ SL 11.0
Aspira-aA+ SL 26.0
Aspira-aA+ SL 23.0
Aspira-aA+ SL 29.0
Aspira-aA+ SL 9.0
Aspira-aA+ SL 2.0
Aspira-aA+ SL 28.0
Aspira-aA+ SL 8.0
Aspira-aA+ SL 6.0
Aspira-aA+ SL 21.0
Aspira-aA+ SL 18.0
Aspira-aA+ SL 13.0
Aspira-aA+ SL 12.0
Aspira-aA+ SL 10.0
Aspira-aA+ SL 27.0
Aspira-aA+ SL 15.0
Aspira-aA+ SL 16.0
Aspira-aA+ SL 30.0
Aspira-aA+ SL 24.0
Aspira-aA+ SL 25.0
Aspira-aA+ SL 19.0
Aspira-aA+ SL 3.0
Aspira-aA+ SL 22.0
Aspira-aA+ SL 7.0
Aspira-aA+ SL 0.0
Aspira-aA+ SL 5.0
Aspira-aA+ SL 14.0
Aspira-aA+ SL 1.0
Aspira-aA+ SL 20.0
Aspira-aA+ SL 4.0
Aspira-aA+ SL 17.0
Device Name
IOLs, aphakic / Family Aspira-aA/Y
Model / Reference
00086450
Primary DI / UDI-DI
04049154499717, 04049154499748, 04049154500048, 04049154499984, 04049154500109, 04049154500529, 04049154500451, 04049154500086, 04049154500512, 04049154500499, 04049154499946, 04049154499885, 04049154499786, 04049154499762, 04049154499724, 04049154500062, 04049154499823, 04049154499847, 04049154500123, 04049154500000, 04049154500024, 04049154499908, 04049154500468, 04049154499960, 04049154500505, 04049154500437, 04049154500482, 04049154499809, 04049154500444, 04049154499922, 04049154500475, 04049154499861
Basic UDI-DI
04049154_PC_M2_H2_O2_BU
EMDN Code
P030102090202 IOLs, APHAKIC, MONOFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000017892

Other devices from HumanOptics Holding AG

See all devices from HumanOptics Holding AG →

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