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RespDirect Collection Kit

by Hologic United States EUDAMED

Ref PRD-07403

EMDN W05019099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54200455DIAGCOLLECTVT Basic UDI-DIDate23 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Collection, Transport and Lysis Kits
Model / Reference
PRD-07403
Primary DI / UDI-DI
25420045515687
Basic UDI-DI
54200455DIAGCOLLECTVT
Unit of Use DI
15420045515680
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000001646
Authorised representative
Hologic BV BE-AR-000000127

Other devices from Hologic

See all devices from Hologic →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 88b4d755-5de3-4959-971b-29c6a6a14cc9 61 fields · synced 23 Oct 2026