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Diagnostic Consumable Kit Auramine V4

by Svizera Europe BV Netherlands EUDAMED

Ref Auramine V4 EMDN W0102010102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number87076967AuramineV4C3 Basic UDI-DIDate7 May 2025RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Diagnostic Consumable Kit Auramine V4
Model / Reference
Auramine V4
Primary DI / UDI-DI
08707696700017
Basic UDI-DI
87076967AuramineV4C3
EMDN Code
W0102010102 Immunoglobulin a subclass reagents
Device Class
Class A

Manufacturer details

EUDAMED SRN
NL-MF-000047495

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • New Device
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 9c3c214f-9580-41f9-9521-f3e48c0a05d6 61 fields · synced 25 Oct 2026