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MassTrak™ Steroid Serum QC Set 2

by Waters Corporation United States EUDAMEDGUDID

Ref 186010564IVD

Product code JJYEMDN W0101050299,W0101050399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number081677602MSTKENDOB5 Basic UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816776020551 UDI-DIDate5 Dec 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
MassTrak™ Steroid Serum QC Set 2 EUDAMED
MassTrak GUDID
Generic Name
Multiple steroid hormone IVD, control
Device Name
MassTrak™ Endocrine Product Family
Model / Ref / Catalog
186010564IVD, 186010565IVD
Primary DI / UDI-DI
00816776020551
Basic UDI-DI
081677602MSTKENDOB5
FDA Product Code
JJY
EMDN Code
W0101050299,W0101050399
GMDN Term
Multiple steroid hormone IVD, control
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
862.1660
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
186010564IVD
GUDID
186010565IVD
Device ClassEUDAMED
Class B
GUDID
Class I

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
  • Human Tissues
  • Reagent
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED aa037f8e-7df1-4c15-af16-2edacf3f528e 61 fields · synced 24 Oct 2026
  • FDA UDI a3c95805-030e-4430-865d-4068716c1503 36 fields · synced 29 May 2026