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PainChek

by PainChek Ltd. EUDAMED

Active European Union

Ref PainChek Infant (iOS Version)Model PainChek Infant

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09360350000008 Basic UDI-DIDate27 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
PainChek Infant
Model / Reference
PainChek Infant, PainChek Infant (iOS Version)
Primary DI / UDI-DI
09360350000008
Basic UDI-DI
B-09360350000008
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
-1192
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
AU-MF-000034893
Authorised representative
Donawa Lifescience Consulting Srl IT-AR-000007785

Other devices from Painchek Ltd

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No