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Hypotonic Solution 1

by Quince Therapeutics S.p.A. EUDAMED

Withdrawn Not intended for the EU market

Ref 09340Model Hypotonic Solution

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805138035HypotonicSolVA Basic UDI-DIDate18 Sep 2026RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 00263-A Issued

    Quality management system EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    17 Sep 2026
    Expires
    16 Sep 2031
  • MDR 00263-B Issued

    Technical documentation EU MDR

    Notified body
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    17 Sep 2026
    Expires
    16 Sep 2031

Specification

EUDAMED

Model / Reference
Hypotonic Solution, 09340
Primary DI / UDI-DI
08051380350089
Basic UDI-DI
805138035HypotonicSolVA
EMDN Code
B99 Haematology and haemotransfusion devices - other
Device Class
Class III

Manufacturer details

EUDAMED SRN
IT-MF-000010896

Properties

  • Sterile

Other properties (12)

  • 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