Skip to content

MammaPrint FFPE microarray

by Agendia N.V Netherlands EUDAMEDGUDID

Ref NA (Centralized Lab Product)

Product code NYIEMDN W05039099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0850024841MammaprintK9 Basic UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850024841321 UDI-DIDate14 Apr 2026ListedStatusIn 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 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
MammaPrint FFPE microarray EUDAMED
MammaPrint FFPE GUDID
Generic Name
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Device Name
MammaPrint Diagnostic Microarray
Model / Reference
NA (Centralized Lab Product) EUDAMED
MammaPrint FFPE Microarray GUDID
Primary DI / UDI-DI
00850024841321
Basic UDI-DI
0850024841MammaprintK9
510(k) Number
FDA Product Code
NYI
EMDN Code
W05039099 Devices for samples analyses - other
GMDN Term
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
866.6040
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NA (Centralized Lab Product)
GUDID
MammaPrint FFPE Microarray
Device ClassEUDAMED
Class C
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000011684

Other devices from Agendia N.V

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Professional Testing
  • Prescription Use
  • Serial Number
Other properties (20)
  • Sterile: No
  • Implantable: No
  • Contains Latex: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED 285f735e-17e4-4f6a-999d-bf523a00d727 61 fields · synced 22 Oct 2026
  • FDA UDI c5118333-e658-482e-b258-015c28f13c09 35 fields · synced 22 Oct 2026