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Vygon Spike 5 µm

by RoweMed AG - Medical 4 Life Germany EUDAMED

Ref 281.02, 281.01 EMDN A0704

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number42503476SPIKEKY Basic UDI-DIDate4 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Trade Name
Vygon Spike 5 µm
Vygon Spike
Device Name
Spike
Model / Reference
281.02, 281.01
Primary DI / UDI-DI
04250347604232, 04250347604225
Basic UDI-DI
42503476SPIKEKY
EMDN Code
A0704 Systems for reconstitution and administration of pharmaceuticals
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
DE-MF-000005350

Other devices from RoweMed AG - Medical 4 Life

See all devices from RoweMed AG - Medical 4 Life →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 7185b535-770c-40fc-9c73-30b660ef8db0 61 fields · synced 22 Oct 2026
  • EUDAMED 04250347604225|42503476SPIKEKY 61 fields · synced 9 Jul 2026