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EASEE System

by Precisis Gesellschaft mit beschränkter Haftung

Ref ESC003

Expiring European Union

CE MDR

Valid until

1 Sep 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

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 Number2245875TD01 Date19 Feb 2026IssuedStatusExpiring expires 1 Sep 2027

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 2245875CE01 Expiring Supplemented Expires in 304 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    11 Mar 2024
    Expires
    1 Sep 2027
    Reason
    Change approved
  • 2245875TD01 Restricted

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    19 Feb 2026
    Expires
    1 Sep 2027
    Reason
    Not on market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Model / Reference
ESC003
Primary DI / UDI-DI
04260479770781
Basic UDI-DI
426047977022426
EMDN Code
J020199 Cerebral implantable neurostimulators - other
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000016826

Properties

  • Sterile
  • Implantable

Other properties (11)

  • 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