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Elara 900

by Haag-Streit AG

Ref 1421004

Expiring European Union

CE MDR

Valid until

6 Jul 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte 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 Number1000313788 Date30 Jul 2026IssuedStatusExpiring expires 6 Jul 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000313788 Expiring Supplemented Expires in 247 days

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    30 Jul 2026
    Expires
    6 Jul 2027
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
Elara 900
Model / Reference
1421004
Primary DI / UDI-DI
07640132988857
Basic UDI-DI
764013298Elara900YE
Direct Marketing DI
07640132988857
EMDN Code
Z12120108 Slit lamps
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000020981
Authorised representative
Haag-Streit Deutschland GmbH DE-AR-000025462

Other devices from Haag-Streit AG

See all devices from Haag-Streit AG →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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