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VITROLIFE SWEDEN AB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039959323003995932VITROLIFE SWEDEN AB1N2026-01-01Gustaf Werners Gata 2 Vastra Frolunda Vastra Gotaland SE SE-421 32

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
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
184031226610361K991273SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLEMQE1999-08-18
184031336441557K894490STERILE ULTRASOUND TRANSMISSION GELJOT1989-10-05
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
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
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
184031046257041
184031288380364
184031373137798
184031800898871
184031977537822

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQL252024-08-07
MQK32020-12-16
MQE32017-11-21
MQH22002-11-05
MQF12025-07-23
ITX12024-08-30
JOT11989-10-05
HEM11986-08-19

PMN#

RAPID-I

2009-12-23

VITROLIFE SWEDEN AB

G-2 V5

2008-09-16

VITROLIFE SWEDEN AB

G-1 V5

2008-09-16

VITROLIFE SWEDEN AB

G-PGD

2004-05-07

VITROLIFE SWEDEN AB

GUDID#

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