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Quantib ND 1.6

by Quantib BV Netherlands EUDAMED510(k)GUDID

Ref 001-160

Product code LLZEMDN Z119082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberSCAR-13.2.2.1 Date26 May 2026IssuedStatusActive expires 1 Aug 2030
United StatesFDA 510(k) 510(k) NumberK213737 Date14 Jan 2022IssuedStatusActive
United StatesGUDID listing GUDID Number08719689791032 UDI-DIDate1 May 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • SCAR-13.2.2.1 Amended

    Quality management system EU MDR

    Notified body
    Notified body 3022
    Issued
    26 May 2026
    Expires
    1 Aug 2030
    Reason
    Other

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Trade Name
Quantib ND 1.6 EUDAMED
Quantib ND GUDID
Generic Name
MRI system application software
Model / Reference
001-160 EUDAMED
1.6 GUDID
Primary DI / UDI-DI
08719689791032
Basic UDI-DI
8719689791PGNDQM
Direct Marketing DI
08719689791032
FDA Product Code
LLZ
EMDN Code
Z119082 Various bioimaging and radiotherapy instruments - software accessories
GMDN Term
MRI system application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
001-160
GUDID
1.6
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000027601

Other devices from Quantib BV

See all devices from Quantib BV →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
Other properties (22)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 8e4f4ecf-44dd-4a83-93cd-acde517be157 61 fields · synced 24 Oct 2026
  • FDA UDI 215e31d3-8d54-4977-b6a8-71655c9f21c6 32 fields · synced 30 May 2026
  • FDA 510(k) K213737 1 fields · synced 18 May 2026