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8mm Gravity Hydrokit

by Transcendencias Comerciales, S.L. Spain EUDAMED

Ref Z-11

EMDN A030499

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberPP12164HKGZ1117 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Z-11
Primary DI / UDI-DI
111787628012
Basic UDI-DI
PP12164HKGZ1117
EMDN Code
A030499 Administration kits - other
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000006640

Other devices from Transcendencias Comerciales S.L

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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 (1)

  • EUDAMED 75340ec8-4114-4915-8129-d5cbe621bb68 61 fields · synced 24 Oct 2026