FDA.reportPublic FDA data

Vitrolife Inc.

Matched from indexed company URL: VITROLIFE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20318243002757762Vitrolife Inc.1Y2026-01-014940 Carroll Canyon Rd Ste 100 San Diego CA US 92121
30032740903003274090Vitrolife Inc.1Y2026-01-013601 South Inca Street Englewood CO US 80110
30038439273003843927Vitrolife GmbH1N2026-01-01Roedersteinstrasse 6 Landshut Bavaria DE 84034
30039959323003995932VITROLIFE SWEDEN AB1N2026-01-01Gustaf Werners Gata 2 Vastra Frolunda Vastra Gotaland SE SE-421 32

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05712714000041EmbryoSlide+ ic8 dish - The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer.The EmbryoSlide+ ic8 dish has 8 culture wells, each to be used for storing a single embryo in individual culture in a microwell inside the well, providing a capacity of 8 embryos. Each well holds 20µL medium. In addition, four rinsing wells are available and can optionally be used if applicable in the specific clinic workflow. Each rinsing well holds 25-30µL medium. The culture area of the dish comprising both culture wells and rinsing wells must be covered with 1.6mL culture oil overlay which will reduce osmolarity changes during culture in a dry environment.The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has a sterility assurance level of 10-6 and is subject to Mouse Embryo Assay (MEA) and endotoxin testing before lot release.The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.+4570230500support.embryoscope@vitrolife.com
05712714603013EmbryoScope time-lapse incubator - The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.+46317218020support.fertility@vitrolife.co
05712714603013EmbryoScope time-lapse incubator - The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.+46317218020support.fertility@vitrolife.com
05712714603013EmbryoScope time-lapse incubator - The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.+4572217900order@vitrolife.com
05712714603013EmbryoScope time-lapse incubator - The EmbryoScope time-lapse incubator (Version D) provides an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.+4570230500support.embryoscope@vitrolife.com
05712714604010EmbryoScope+ - EmbryoScope+ consists of the following devices with the following indications for use:The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by theEmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotatedinformation on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not controlany hardware components in the EmbryoScope+ incubator.The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.+4570230500support.embryoscope@vitrolife.
05712714604010EmbryoScope+ - EmbryoScope+ consists of the following devices with the following indications for use:The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by theEmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotatedinformation on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not controlany hardware components in the EmbryoScope+ incubator.The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.+4570230500support.embryoscope@vitrolife.com
05712714663505EmbryoSlide culture dish - The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.The EmbryoSlide culture dish contains two types of wells: wells, which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The EmbryoSlide culture dish fits exactly on the culture dish holder in the EmbryoScope time-lapse incubator and holds a maximum of 12 embryos in separate microwells. The EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos and 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation.. Each well has a volume of 25 μl. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 μm.+4570230500support.embryoscope@vitrolife.
05712714663505EmbryoSlide culture dish - The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.The EmbryoSlide culture dish contains two types of wells: wells, which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The EmbryoSlide culture dish fits exactly on the culture dish holder in the EmbryoScope time-lapse incubator and holds a maximum of 12 embryos in separate microwells. The EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos and 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation.. Each well has a volume of 25 μl. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 μm.+4570230500support.embryoscope@vitrolife.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1229531253113208K993140WATER FOR TISSUE CULTURE, MODELS 1500MTW2000-08-02
184031884543456K991700SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZOMQH1999-07-19
184031747130039K991351OVOIL-150, MODEL 5002MQL2000-02-25
184031623944338K991345ASP-100, MODEL 2100MQL2000-02-18
1229531782728448K991322ENHANCE-S PLUSMQL1999-07-26
184031226610361K991273SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLEMQE1999-08-18
1229531833772777K991104MICROTOOLSMQH1999-07-19
184031336441557K894490STERILE ULTRASOUND TRANSMISSION GELJOT1989-10-05
1229531753469065K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)CEP1987-07-27
184031020441454K862364NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)HEM1986-08-19
184031994196888K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)MQF2025-07-23
184031701401692K241662Ultrasound Transducer CoverITX2024-08-30
184031968361632K240605Ultra RapidWarm™ BlastMQL2024-08-07
184031435005007K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSMQL2021-05-14
184032068772255K201213Pasteur Pipette 3mL, Pasteur Pipette 1mLMQK2020-12-16
667601814593792K192008LaserShot M, NaviLaseMRX2020-03-25
184031963209282K183486RapidVit™ Oocyte, RapidWarm™ OocyteMQL2019-07-26
184031978595360K181461Rapid-i™ KitMQK2019-01-04
184031473408640K172050Follicle Aspiration Set, Reduced Single LumenMQE2017-11-21
184031392011502K161970Follicle Aspiration SetMQE2017-06-14
184031637417529K150950FreezeKit Cleave , ThawKit CleaveMQL2015-12-21
184031008060616K133568G-TLMQL2014-07-16
184031648688508K101003RAPIDVIT BLAST, RAPIDWARM BLASTMQL2010-12-10
184031984543145K090832RAPID-IMQK2009-12-23
184031440398204K081117G-2 V5MQL2008-09-16
184031252259766K081116G-IVF G5 SERIESMQL2008-09-02
184031623465599K081115G-MOPS G5 SERIESMQL2008-09-17
184031951898948K081114G-1 V5MQL2008-09-16
184031170597126K080446RAPIDVIT AND RAPIDWARM CLEAVEMQL2008-11-26
184031236923733K043116ICSI-100MQL2005-01-13
184031729801137K033101G-PGDMQL2004-05-07
184031615189688K032155G-THAWKIT BLASTMQL2004-05-07
184031006257125K031015EMBRYOGLUEMQL2003-06-23
1229531574232204K030117ENHANCE SPERM FREEZEMQL2003-03-20
1229531152787100K030116ENHANCE-S PLUS HMQL2003-02-12
1229531036905112K023717SPERM WASH MEDIUM WITH GENTAMICINMQL2002-12-13
1229531354755226K023655ENHANCE HTF MEDIUM WITH HEPESMQL2002-12-13
184031320917841K023403SPERMGRAD, MODELS 10022/10063MQL2002-12-13
184031243788046K022643BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540MQH2002-11-05
184031464170195K022295G-RINSE, MODEL 10031MQL2002-09-12
184031246185177K021896HSA-SOLUTION, MODEL 10034/10064MQL2002-09-06
184031389665967K021894G-MM, MODEL 10038MQL2002-09-06
184031133027866K000627SCANDINAVIAN IVF SCIENCES AB, HYBASE-1MQL2000-06-13
184031888954048K000623SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1MQL2000-05-16
184031522511712K000621SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100MQL2000-05-16
184031016009425K000618SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1MQL2000-05-17
184031953987128
969001008060616
184031046257041
969001252259766
184031288380364
969001288380364
969001320917841
1229531354507925
969001362400525
184031373137798
969001435005007
969001440398204
969001464170195
969001522511712
969001623465599
969001623944338
969001747130039
184031800898871
969001951898948
1229531977537822
184031977537822

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQL302024-08-07
MQK32020-12-16
MQE32017-11-21
MQH32002-11-05
MQF12025-07-23
ITX12024-08-30
MRX12020-03-25
MTW12000-08-02
JOT11989-10-05
CEP11987-07-27
HEM11986-08-19

PMN#

G-TL

2014-07-16

VITROLIFE, INC.

RAPID-I

2009-12-23

VITROLIFE SWEDEN AB

G-1 V5

2008-09-16

VITROLIFE SWEDEN AB

G-2 V5

2008-09-16

VITROLIFE SWEDEN AB

G-PGD

2004-05-07

VITROLIFE SWEDEN AB

50 records. Showing 1-40. Next

GUDID#

Micro well group culture dish, 16-well - The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The sixteen (16) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture.The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6).Indications for Use / Intended Use:For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.

Vitrolife A/S

2017-09-21

Micro well group culture dish, 9-well - The Micro Well Group Culture Dish is designed for efficient embryo handling and culture. The nine (9) microwells are intended for embryo culture at all stages. The wells are intended to hold one embryo each. The area surrounding the wells can contain a sufficient amount of culture medium for all embryos, thereby allowing efficient culture setup and handling. The individual microwells allows individual evaluation of each embryo during group culture.The Micro Well Group Culture Dish is constructed of polysterene and is non-pyrogenic. The raw material has passed mouse embryo testing prior to production and the dish is sterilised by beta irradiation. Sterility Assurance level 10-6 (SAL 10-6).Indications for Use / Intended Use:For in vitro fertilisation, handling and embryo culture. It may be used for culturing of embryos using drop culture.

Vitrolife A/S

2017-09-21

EmbryoSlide+ culture dish - The EmbryoSlide+ culture dish is a radiation-sterilized polystyrene culture dish containing two separate reservoirs. Each reservoir has eight culture wells, and each well is used to culture one embryo. Therefore, a total of 16 embryos can be cultured on one dish. Each dish includes four special wells that are only used for rinsing and handling the embryos either before or after incubation. An adhesive barcode label printed from the EmbryoViewer software is used to mark each dish. The barcode label contains two different 2D data matrices that provide information on the patient (name, patient ID, treatment ID, and insemination time). The EmbryoSlide+ culture dish has a sterility assurance level of 10-6 and a shelf-life of four years. This device is subject to mouse embryo assay (MEA) and endotoxin testing before lot release.

Vitrolife A/S

2018-05-24

EmbryoSlide culture dish - The EmbryoSlide culture dish is intended for preparing, storing, and transferring human embryos. It is intended to be used only with the EmbryoScope device.The EmbryoSlide culture dish contains two types of wells: wells, which are only used for rinsing and handling the embryos before or after incubation and wells in which the embryos reside during incubation. The EmbryoSlide culture dish fits exactly on the culture dish holder in the EmbryoScope time-lapse incubator and holds a maximum of 12 embryos in separate microwells. The EmbryoSlide culture dish contains a large oil reservoir with 12 wells for the incubation of 12 individual embryos and 4 special wells, two at each end of the culture dish that are intended for rinsing and general handling of the embryos either before or after incubation.. Each well has a volume of 25 μl. Inside each well there is a central depression where the embryo rests. The well has a diameter of approximately 250 μm.

Vitrolife A/S

2016-08-26

EmbryoScope+ - EmbryoScope+ consists of the following devices with the following indications for use:The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development.The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator.The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by theEmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotatedinformation on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not controlany hardware components in the EmbryoScope+ incubator.The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters.The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.

Vitrolife A/S

2018-05-24

KIDScore D3 - The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyststage by scoring them according to their statistical viability.Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezingor continued embryo development when, following morphological assessment on Day 3, there are multiple embryosdeemed suitable for transfer or freezing.The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.

Vitrolife A/S

2019-11-28

EmbryoSlide+ ic8 dish - The EmbryoSlide+ ic8 dish is a single use, sterile accessory specially designed for embryo culture, handling and preparation for transfer.The EmbryoSlide+ ic8 dish has 8 culture wells, each to be used for storing a single embryo in individual culture in a microwell inside the well, providing a capacity of 8 embryos. Each well holds 20µL medium. In addition, four rinsing wells are available and can optionally be used if applicable in the specific clinic workflow. Each rinsing well holds 25-30µL medium. The culture area of the dish comprising both culture wells and rinsing wells must be covered with 1.6mL culture oil overlay which will reduce osmolarity changes during culture in a dry environment.The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has a sterility assurance level of 10-6 and is subject to Mouse Embryo Assay (MEA) and endotoxin testing before lot release.The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.

Vitrolife A/S

2022-08-20

EmbryoViewer - The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not control any hardware components in the EmbryoScope+ incubator. The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.

Vitrolife A/S

2026-04-16

ES server - The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.

Vitrolife A/S

2026-04-16

90 records. Showing 1-40. Next