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GiPSEweb

by Dedalus Italia SpA Italy EUDAMED

Ref GiPSEwebModel ER4H FirstAid Web

EMDN V92

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805572803ER4HDK Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00290-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    31 Jan 2026
    Expires
    15 Nov 2027

Specification

EUDAMED · synced 22 Oct 2026

Device Name
ER4H FirstAid Web
Model / Reference
ER4H FirstAid Web, GiPSEweb
Primary DI / UDI-DI
08055728031111, 08055728031029, 08055728030879
Basic UDI-DI
805572803ER4HDK
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000009127

Other devices from Dedalus Italia SpA

See all devices from Dedalus Italia SpA →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (3)

  • EUDAMED d73b2d1b-f47b-4948-9cb7-33760b9bd8e4 61 fields · synced 22 Oct 2026
  • EUDAMED 08055728031029|805572803ER4HDK 61 fields · synced 18 Jun 2026
  • EUDAMED 08055728030879|805572803ER4HDK 61 fields · synced 10 Jul 2026