Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003274090

FEI Number

3003274090

Entity Name

Vitrolife Inc.

City/State/Country

Englewood, CO, US

Establishment Address

3601 South Inca Street, Englewood, CO 80110, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

G-RINSE G-1 PLUS G-MOPS/G-MOPS PLUS G-GAMETE G-IVF PLUS SpermGrad Gx-IVF Gx-MOPS PLUS Gx-TL G-TL ASP OVOIL HEAVY OVOIL G-2 PLUS OVOIL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2007-11-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-12-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-12-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2019-02-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-12-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2007-11-12
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2021-05-18
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-08-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2007-11-12
QKI	Media, Reproductive, Exempt	Obstetrics/Gynecology	Class 2	884.6180	2020-08-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-12-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2007-11-12

Official Correspondent

NINA ARVIDSSON

US Agent Details

No US Agent registered (Local establishment).

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
3003995932	VITROLIFE SWEDEN AB	Vastra Frolunda Vastra Gotaland, SE
2031824	Vitrolife Inc.	San Diego, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

Similar Registrations

Registration Number	Establishment Name	Location
2031824	Vitrolife Inc.	San Diego, CA, US
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR
3014755376	CooperSurgical Distribution B.V.	Herten Limburg, NL
3036725842	GYNOTEC B.V.	Malden Gelderland, NL
3004048494	ORIGIO A/S	Ballerup Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003274090. Last updated year: 2026. Please use registration number 3003274090 when referencing this establishment in official correspondence.