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Zn-Air Battery Pak

by Advanced Bionics LLC 16 variants

Ref CI-5500-130

Active European Union

CE MDR

Valid until

6 Feb 2029

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 NumberG70 077725 0027 Date2 Sep 2026IssuedStatusActive expires 6 Feb 2029

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • G70 077725 0027 Active Supplemented

    Technical documentation EU MDR

    Certifier
    TÜV SÜD Product Service GmbH 0123
    Issued
    2 Sep 2026
    Expires
    6 Feb 2029
    Reason
    Add device or group

Coverage

1 jurisdiction

NorwaySwedenFinlandLatviaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyTürkiyeCroatiaGreeceCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

EU market availability

Made available in 26 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Austria since 7 Feb 2024
  • Belgium since 7 Feb 2024
  • Bulgaria since 7 Feb 2024
  • Croatia since 7 Feb 2024
  • Cyprus since 7 Feb 2024
  • Czechia since 7 Feb 2024
  • Denmark since 7 Feb 2024
  • Finland since 7 Feb 2024
  • France since 7 Feb 2024
  • Germany since 7 Feb 2024
  • Greece since 7 Feb 2024
  • Hungary since 7 Feb 2024
  • Ireland since 7 Feb 2024
  • Italy since 7 Feb 2024
  • Latvia since 7 Feb 2024
  • Lithuania since 7 Feb 2024
  • Luxembourg since 7 Feb 2024
  • Netherlands since 7 Feb 2024
  • Norway since 7 Feb 2024
  • Poland since 7 Feb 2024
  • Portugal since 7 Feb 2024
  • Romania since 7 Feb 2024
  • Slovenia since 7 Feb 2024
  • Spain since 7 Feb 2024
  • Sweden since 7 Feb 2024
  • Türkiye since 7 Feb 2024

Last checked 28 Oct 2026.

Specification

EUDAMED

Model / Reference
CI-5500-130
Primary DI / UDI-DI
00840094471207, 00840094480322
Basic UDI-DI
08400944CI5500XU
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 GmbH DE-AR-000005642

Other devices from Advanced Bionics

  • PowerCel™ 110 Mini

    Class III

  • RF Cable

    Class III

  • Zn-Air Battery Pak

    Class III

  • Naida CI Q70

    Class III

  • PowerCel™ 110

    Class III

  • Naida CI Q90

    Class III

See all devices from Advanced Bionics →

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