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HiFocus SlimJ Electrode Depth Gauge

by Advanced Bionics LLC

Ref CI-1605

Expiring European Union

CE MDR

Valid until

21 Sep 2027

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08400944CI1605XF Basic UDI-DI 00840094495630UDI-DIDate21 Jul 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 077725 0026 Expiring Supplemented Expires in 325 days

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    29 Jun 2026
    Expires
    21 Sep 2027
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Model / Reference
CI-1605
Primary DI / UDI-DI
00840094495630
Basic UDI-DI
08400944CI1605XF
EMDN Code
J0380 Auditory active-implantable devices - accessories
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000019344
Authorised representative
Advanced Bionics Logistic Services GmbH DE-AR-000056289

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Properties

  • Sterile

Other properties (12)

  • 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