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CergenX Limited

Ireland IE-MF-000049455 Last updated 8 Jun 2026

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Devices
3
Registries
EUDAMED
FDA recalls
0

Catalogue3

  • Wave Ref 1.0

    Class IIb EUDAMED Active

  • Wave Ref 1.0

    Class IIb EUDAMED Active

  • Wave Ref 1.1

    Class IIb EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 2797 1 certificate

  • MDR 825687 Issued

    Quality management system EU MDR

    Issued
    24 Jul 2026
    Expires
    23 Jul 2031

Related companies

Notified bodies

  • Notified body 2797

About

CergenX is rethinking neonatal EEG. Our state-of-the-art AI platform is expanding the clinical utility of EEG, moving it beyond specialist-dependent applications to deliver accessible bedside assessments and actionable insights to non-specialist clinicians.

From the manufacturer's own website. Source

Information

Country
Ireland
Address
23, Green Park, Dublin, Ireland
Phone
+353 1 513 11 76
PRRC contact
Thais Sala
EUDAMED SRN
IE-MF-000049455