Data / Medical devices / Denmark / Vitrolife A/S

Vitrolife A/S: FDA-registered device maker in Viby J Midtjylland, Denmark, 8 510(k) clearances

Name: Vitrolife A/S FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vitrolife A/S is registered with the FDA (registration 3009107689) in Viby J Midtjylland, Denmark. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 11, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009107689
Address: Jens Juuls Vej 16, Viby J Midtjylland, Denmark, 8260
Owner or operator: Vitrolife A/S (10040532)
Roles: Contract manufacturer, Manufacturer, Specification developer
First device listed: April 23, 2012
Registered through: 2026
Brand names listed: ES Server software, EmbryoScope Version D, EmbryoScope Version D and EmbryoSlide, EmbryoScope Version D and EmbryoViewer software, EmbryoScope time-lapse incubator, EmbryoScope+ incubator, EmbryoSlide culture dish, EmbryoSlide+ culture dish and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Assisted Reproduction	MQG	2	Manufacturer, Specification developer	accessdata.fda.gov
Embryo Image Assessment System, Assisted Reproduction	PBH	2	Manufacturer	accessdata.fda.gov
Labware, Assisted Reproduction	MQK	2	Manufacturer, Specification developer	accessdata.fda.gov
Microscope And Microscope Accessories, Reproduction, Assisted	MTX	1	Manufacturer	accessdata.fda.gov
System, Assisted Reproduction Laser	MRX	2	Contract 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
March 11, 2022	K213869	EmbryoSlide+ ic8 dish	MQK	Substantially Equivalent	Vitrolife A/S	accessdata.fda.gov
July 19, 2019	K182798	KIDScore D3	PBH	Substantially Equivalent	Vitrolife A/S	accessdata.fda.gov
May 11, 2018	K173264	EmbryoScope+	MQG	Substantially Equivalent	Vitrolife A/S	accessdata.fda.gov
December 4, 2015	K150961	EmbryoSlide Culture Dish	MQK	Substantially Equivalent	Vitrolife A/S	accessdata.fda.gov
August 8, 2014	K133712	EMBRYOVIEWER SOFTWARE	MQG	Substantially Equivalent	Unisense Fertilitech A/S	accessdata.fda.gov
December 21, 2011	K113075	EMBRYO VIEWER SOFTWARE	MQG	Substantially Equivalent	Unisense Fertilitech A/S	accessdata.fda.gov
August 11, 2011	K111715	EMBRYOSCOPE	MQG	Substantially Equivalent	Unisense Fertilitech A/S	accessdata.fda.gov
January 11, 2011	K092183	EMBRYOSCOPE AND EMBRYOSLIDE	MQG	Substantially Equivalent	Unisense Fertilitech A/S	accessdata.fda.gov

Compare with other makers

Updated March 11, 2022. 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.