Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2031824

FEI Number

3002757762

Entity Name

Vitrolife Inc.

City/State/Country

San Diego, CA, US

Establishment Address

4940 Carroll Canyon Rd Ste 100, San Diego, CA 92121, US

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

Expiration Date (Year)

2026

510(k) Number

K023655

PMA Number

N/A

All Registered Proprietary Names

ENHANCE SPERM FREEZE Enhance Sperm Wash with & without Gentamicin PZD Pipette Handling Pipette Biopsy Pipette ICSI Pipette Hatching Pipette Holding Pipette ENHANCE-S PLUS HTF CELL ISOLATION MEDIUM OvuQuick One Step Ovulation Predictor Test MicroCell mHTF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-11-18
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-11-18
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2022-12-05
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-11-18
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2014-08-29
GHO	Hemocytometer	Hematology	Class 1	864.6160	2018-04-20
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-11-18

Official Correspondent

No official correspondent registered.

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
3003274090	Vitrolife Inc.	Englewood, CO, US
3003995932	VITROLIFE SWEDEN AB	Vastra Frolunda Vastra Gotaland, SE

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

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3036725842	GYNOTEC B.V.	Malden Gelderland, NL
3004048494	ORIGIO A/S	Ballerup Hovedstaden, DK
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031824. Last updated year: 2026. Please use registration number 2031824 when referencing this establishment in official correspondence.