VITROLIFE SWEDEN AB

FDA Device Registration & Listing · Vastra Frolunda Vastra Gotaland, SE · Registration 3003995932

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003995932
FEI Number
3003995932
Entity Name
VITROLIFE SWEDEN AB
City/State/Country
Vastra Frolunda Vastra Gotaland, SE
Establishment Address
Gustaf Werners Gata 2, Vastra Frolunda Vastra Gotaland SE-421 32, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
VITROLIFE AB (Owner Number: 9037178)
Owner / Operator Contact Address
Gustaf Werners gata 2, Vastra Frolunda, SE-O SE-421 32, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm G-IVF PLUS Rapid-i Kit HSA-solution RapidVit Cleave/RapidWarm Cleave G-TL EmbryoGlue G-RINSE OVOIL RapidVit Blast, RapidWarm Blast SpermRinse PZD Pipette Handling Pipette Biopsy Pipette ICSI Pipette Hatching Pipette Holding Pipette Ultra RapidWarm Blast RapidWarm Oocyte RapidVit Oocyte FreezeKit Cleave, ThawKit Cleave Follicle Aspiration Set, Single Lumen Follicle Aspiration Set, Single Lumen Luer with Tubing Follicle Aspiration Set, Single Lumen, Luer Follicle Aspiration Set, Double Lumen Follicle Aspiration Set, Reduced Single Lumen Follicle Aspiration Set, Reduced Single Lumen, Luer Follicle Aspiration Set, Reduced Double Lumen Amniocentesis Needle Gx-IVF Gx-MOPS PLUS Gx-TL G-2 PLUS Vacuum Pump Tubing Culture Dish 40 mm Culture Dish 60 mm 5 Well Culture Dish Centrifuge Tube 50 mL Collection Dish 90 mm Centre Well Dish ICSI Dish Sample Tube 5 mL Centrifuge Tube 15 mL Micro-droplet Culture Dish Oocyte Collection Tube 14 mL Sperm Collection Container G-PGD ICSI Pasteur Pipette 3 mL Pasteur Pipette 1 mL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2026-05-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-12-10
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2019-11-22
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2007-11-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-12-16
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2015-08-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2007-11-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2007-11-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2007-11-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2011-12-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2007-11-12
PUC Microtools, Assisted Reproduction (Pipettes), Exempt Obstetrics/Gynecology Class 2 884.6130 2022-12-05
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2024-09-06
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-11-22
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2018-02-14
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2017-08-21
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2018-01-03
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2018-01-03
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2021-05-18
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2008-12-10
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2019-06-10
PUD Labware, Assisted Reproduction, Exempt Obstetrics/Gynecology Class 2 884.6160 2024-06-17
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2007-11-12
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2007-11-12
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2024-03-05

Official Correspondent

NINA ARVIDSSON

US Agent Details

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

Related Public Records

Same Entity

VITROLIFE AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003274090 Vitrolife Inc. Englewood, CO, US
2031824 Vitrolife Inc. San Diego, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K112396 Kitazato Medical Co., Ltd. IUI CATHETERS 2012-11-02
K011481 Conception Technologies 10% PVP; 10% PVP IN EBSS SOLUTION 2001-07-02
K082727 Vitrolife Sweden AB FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN 2009-02-06
K910471 Baxter Healthcare Corp MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE 1991-03-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003995932. Last updated year: 2026. Please use registration number 3003995932 when referencing this establishment in official correspondence.
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