Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009107689

FEI Number

3009107689

Entity Name

Vitrolife A/S

City/State/Country

Viby J Midtjylland, DK

Establishment Address

Jens Juuls Vej 16, Viby J Midtjylland 8260, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vitrolife A/S (Owner Number: 10040532)

Owner / Operator Contact Address

Jens Juuls Vej 16, Viby J, DK-NOTA 8260, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K113075

PMA Number

N/A

All Registered Proprietary Names

KIDScore D3 EmbryoSlide+ ic8 dish EmbryoScope Version D and EmbryoSlide EmbryoScope time-lapse incubator EmbryoViewer EmbryoSlide+ culture dish ES Server software EmbryoViewer software EmbryoScope+ incubator EmbryoSlide culture dish EmbryoScope Version D EmbryoScope Version D and EmbryoViewer software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PBH	Embryo Image Assessment System, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6195	2019-09-20
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2022-04-04
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2012-04-23
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2012-04-23
MTX	Microscope And Microscope Accessories, Reproduction, Assisted	Obstetrics/Gynecology	Class 1	884.6190	2012-04-23
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2016-08-19
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2018-05-22
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2018-05-22
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2015-12-09
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2012-04-23
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2012-04-23

Official Correspondent

Belinda Dueholm

US Agent Details

Erin Schardt Business: Vitrolife Inc. Email: eschardt@vitrolife.com Phone: (727) 4247916

Related Public Records

Same Entity

Vitrolife A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

Similar Registrations

Registration Number	Establishment Name	Location
3042972064	FAIRTILITY LTD.	Tel Aviv, IL
3042372505	ALIFE HEALTH, INC.	San Francisco, CA, US
3012416874	Elos Medtech Skara AB	Skara Vastra Gotaland, SE
3014527900	DxNow Inc.	Gaithersburg, MD, US
3010781586	BIOTECH, INC.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009107689. Last updated year: 2026. Please use registration number 3009107689 when referencing this establishment in official correspondence.