Data / Medical devices / Netherlands / Finapres Medical Systems B.V.

Finapres Medical Systems B.V.: FDA-registered device maker in Enschede Overijssel, Netherlands, 1 510(k) clearance

Name: Finapres Medical Systems B.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Finapres Medical Systems B.V. is registered with the FDA (registration 3003803088) in Enschede Overijssel, Netherlands. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 6, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003803088
Address: Institutenweg 25, Enschede Overijssel, Netherlands, 7521 PH
Owner or operator: FINAPRES MEDICAL SYSTEMS B.V. (9051428)
Roles: Manufacturer
First device listed: November 29, 2018
Registered through: 2026
Brand names listed: Finapres NOVA NanoCore

Devices it lists

Device	Product code	Class	Role	Source
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 6, 2018	K173916	Finapres Nova Noninvasive Hemodynamic Monitor	DXN	Substantially Equivalent	Finapres Medical Systems B.V.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 6, 2012	62556	Class II	Terminated	Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in t	Battery may become hot and leak	accessdata.fda.gov

Compare with other makers

Updated November 6, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.