Skip to content

ABBOTT FFR Connection Kit

by Fysicon B.V. Netherlands EUDAMEDGUDID

Ref 01076155

Product code DSAEMDN Z12050785

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08720938410444 UDI-DIDate14 Aug 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number8719689142QMAPPCONSKJ Basic UDI-DIDate16 May 2023RegisteredStatusActive

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/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
Multiple physiological parameter monitoring support kit
Device Name
QMAPP Consumables
Model / Ref / Catalog
01076155 EUDAMED
ABBOTT FFR Connection Kit GUDID
01976155 GUDID
Primary DI / UDI-DI
08720938410444
Basic UDI-DI
8719689142QMAPPCONSKJ
510(k) Number
FDA Product Code
DSA
EMDN Code
Z12050785 Instruments for cardiological polygraphy - consumables
GMDN Term
Multiple physiological parameter monitoring support kit
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2900
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
01076155
GUDID
ABBOTT FFR Connection Kit
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000002694

Other devices from Fysicon B.V.

See all devices from Fysicon B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Lot / Batch Number
  • Manufacturing Date
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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 413c9e9a-820b-4be9-ad0f-dc75f4bf5815 61 fields · synced 23 Oct 2026
  • FDA UDI 9e9b46a1-09ca-4661-b25e-33c75a8884ae 35 fields · synced 23 Oct 2026