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Data / Medical devices / Sweden / Vitrolife Sweden AB

Vitrolife Sweden AB: FDA-registered device maker in Vastra Frolunda Vastra Gotaland, Sweden, 26 510(k) clearances

Vitrolife Sweden AB is registered with the FDA (registration 3003995932) in Vastra Frolunda Vastra Gotaland, Sweden. It lists 10 device types. The FDA files 26 510(k) clearances under its listings, the newest dated July 23, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Vitrolife Sweden AB
FDA registration number
3003995932
Address
Gustaf Werners Gata 2, Vastra Frolunda Vastra Gotaland, Sweden, SE-421 32
Owner or operator
VITROLIFE AB (9037178)
Roles
Manufacturer
First device listed
November 12, 2007
Registered through
2026
Brand names listed
5 Well Culture Dish, ASP, Amniocentesis Needle, Biopsy Pipette, Centre Well Dish, Centrifuge Tube 15 mL, Centrifuge Tube 50 mL, Collection Dish 90 mm and more

Devices it lists

DeviceProduct codeClassRoleSource
Catheter, Assisted ReproductionMQF2Manufactureraccessdata.fda.gov
Labware, Assisted ReproductionMQK2Manufactureraccessdata.fda.gov
Labware, Assisted Reproduction, ExemptPUD2Manufactureraccessdata.fda.gov
Media, ReproductiveMQL2Manufactureraccessdata.fda.gov
Media, Reproductive, ExemptQKI2Manufactureraccessdata.fda.gov
Microtools, Assisted Reproduction (Pipettes), ExemptPUC2Manufactureraccessdata.fda.gov
Needle, Assisted ReproductionMQE2Manufactureraccessdata.fda.gov
Sampler, Amniotic Fluid (Amniocentesis Tray)HIO1Manufactureraccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Manufactureraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 23, 2025K243373Embryo 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)MQFSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
August 30, 2024K241662Ultrasound Transducer CoverITXSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
August 7, 2024K240605Ultra RapidWarm™ BlastMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
May 14, 2021K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
December 16, 2020K201213Pasteur Pipette 3mL, Pasteur Pipette 1mLMQKSubstantially EquivalentHertart Apsaccessdata.fda.gov
July 26, 2019K183486RapidVit™ Oocyte, RapidWarm™ OocyteMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
January 4, 2019K181461Rapid-i™ KitMQKSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
November 21, 2017K172050Follicle Aspiration Set, Reduced Single LumenMQESubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
June 14, 2017K161970Follicle Aspiration SetMQESubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
December 21, 2015K150950FreezeKit Cleave , ThawKit CleaveMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
July 16, 2014K133568G-TLMQLSubstantially EquivalentVitrolife, Inc.accessdata.fda.gov
December 10, 2010K101003RAPIDVIT BLAST, RAPIDWARM BLASTMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
November 26, 2008K080446RAPIDVIT AND RAPIDWARM CLEAVEMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
September 17, 2008K081115G-MOPS G5 SERIESMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
September 16, 2008K081117G-2 V5MQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
September 16, 2008K081114G-1 V5MQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
September 2, 2008K081116G-IVF G5 SERIESMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
January 13, 2005K043116ICSI-100MQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
May 7, 2004K033101G-PGDMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
June 23, 2003K031015EMBRYOGLUEMQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
December 13, 2002K023403SPERMGRAD, MODELS 10022/10063MQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
September 12, 2002K022295G-RINSE, MODEL 10031MQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
September 6, 2002K021896HSA-SOLUTION, MODEL 10034/10064MQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov
June 13, 2000K000627SCANDINAVIAN IVF SCIENCES AB, HYBASE-1MQLSubstantially EquivalentVitrolife AB/Scandinavian Ivf Sciences ABaccessdata.fda.gov
May 16, 2000K000621SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100MQLSubstantially EquivalentVitrolife AB/Scandinavian Ivf Sciences ABaccessdata.fda.gov
February 18, 2000K991345ASP-100, MODEL 2100MQLSubstantially EquivalentVitrolife Sweden ABaccessdata.fda.gov

Compare with other makers

Updated July 23, 2025. 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.