Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004048494

FEI Number

3004048494

Entity Name

ORIGIO A/S

City/State/Country

Ballerup Hovedstaden, DK

Establishment Address

Lautrupvang 2, 1st, Ballerup Hovedstaden 2750, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ORIGIO A/S (Owner Number: 9012179)

Owner / Operator Contact Address

Lautrupvang 2, 1st, --, Ballerup, DK-NOTA 2750, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K003163

PMA Number

N/A

All Registered Proprietary Names

In Vitro Maturation Media Kit ART-1600 ORIGIO® Sequential media 8301, 8302, 8303, 8304 Oil for Tissue Culture ART-4008, ART-4008-5, ART-4009W, ART-4009-5W Phosphate Buffered Saline wo Ca, Mg, Glucose, Pyruvate, Phenol Red ART-4011, ART-4012 VitriGuard 4378, 4379, 4380, 4381, 4382, 4384, 4385, 4386 Embryo Freezing Pack 1026, Embryo Thawing Pack 1098 Biopsy Medium 1062 Embryogen 1203 SAGE 1-STEP GM-CSF w SPS 7702 SAGE 1-STEP GM-CSF w HSA 7701 MediCult IVM® System 8221 Quinn's Sperm Washing Medium ART-1005, ART-1006 Quinn's Sperm Washing medium wo antibiotics ART-1012 Universal IVF Medium 1030, 1031 CSC Thawing Medium ARt-8018 CSC Freezing Medium ART-8017 Quinn's Advantage ARt-8015, ART-8016, ART-8017 Medicult (MC) Vitrification 1228, 1229 Liquid Paraffin 1010 PVP 10% Ready-To-Use Solution ART-4006-A PVP 7% Ready-To-Use Solution in HEPES-HTF ART-4005-A BlastAssist® 1215, 1216 VitriGuard 4382, 4384, 4385, 4386, 4378, 4379, 4380, 4381 PVP Medium 1089, PVP Clinical Grade 1090 ORIGIO Gradient 90 (8401), Gradient 100 (8400), Gradient 40/80 (8402), SpermWash 8405 Flushing Medium w/o Heparin 1084 BlastFreeze 1053, BlastThaw 1054 BlastAssist® System 1039, 1040, 1045, 1047 Blastgen 1205 SAGE 1-Step w HSA 6701, SAGE 1-Step w SPS 6702 Embryo Assist 1213, 1314 SpermSlow 1094 SynVitro® Hyadase 1511 Hyaluronidase 80 U/ml in HEPES-HTF ART-4007-A Kit 1206 EmbryoGen® (1204) Syn Vitro® Flush w/o Heparin 1584

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-05-20
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2014-05-15
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-05-20
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-05-20
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2017-03-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-02-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2007-11-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2012-12-03
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2017-11-03
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-09-23
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-05-20
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-02-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-05-19
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-12-06
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-02-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-05-19
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-02-11
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2018-11-07
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-02-11
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2016-12-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-02-16
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-09-23
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-09-23
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2016-03-10
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2014-04-30
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-09-23
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-09-23
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-09-23
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2015-05-20
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2014-07-22
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2008-09-23

Official Correspondent

Brith Nordberg

US Agent Details

Brian Szeremeta Business: Vice President, Quality Assurance Operations CSI RAQA Email: brian.szeremeta@coopersurgical.com Phone: (475) 2396814

Related Public Records

Same Entity

ORIGIO A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004048494. Last updated year: 2026. Please use registration number 3004048494 when referencing this establishment in official correspondence.