Skip to content

MassTrak™

by Waters Corporation United States EUDAMED

Ref 186008441IVD

EMDN W0102060309

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number081677602VTDKIT0608D9 Basic UDI-DIDate15 Apr 2024RegisteredStatusActive

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
Masstrak™ Vitamin D Kit
Model / Reference
186008441IVD
Primary DI / UDI-DI
00816776020414
Basic UDI-DI
081677602VTDKIT0608D9
EMDN Code
W0102060309 25-hydroxyvitamin d
Device Class
Class B
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000025801
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Waters Corporation

See all devices from Waters Corporation →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 9f4ac695-5ea4-4fe6-b381-fbe8c18867fc 61 fields · synced 23 Oct 2026