BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    ORIGIO A/S

    Reg #: 3004048494 · FEI: 3004048494 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    53
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ORIGIO A/S
    Registration Number
    3004048494
    FEI Number
    3004048494
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Lautrupvang 2, 1st
    City
    Ballerup Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K053646

    Owner / Operator

    Firm Name
    ORIGIO A/S
    Operator Number
    9012179
    Address
    Lautrupvang 2, 1st, --
    City
    Ballerup
    State
    DK-NOTA
    Postal Code
    2750
    Country
    DK
    Correspondent
    Brith Nordberg

    US Agent

    Business Name
    Vice President, Quality Assurance Operations CSI RAQA
    Contact Name
    Brian Szeremeta
    Address
    Coopersurgical Inc., 95 Corporate Dr
    City
    Trumbull
    State
    CT
    ZIP
    06611
    Country
    US
    Email
    [email protected]
    Phone
    475 2396814

    Products

    Device Name Product Code
    Media, Reproductive MQL
    Labware, Assisted Reproduction MQK

    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 Sperm Preparation Medium 1069, 1070 SAGE Vitrification Kit with Straws ART-8025-HSV Pureception ART-2004, ART-2016, ART-2024, ART-2040, ART-2080, ART-2100 Quinn's Advantage SPS Serum Protein Substitute ART-3010, ART-3011 Sperm Freezing Medium 1067 Quinn's Advantage ART-1520, ART-1526, ART-1529, ART-1729, ART-4013-A, ART-4100 Quinn's Advantage ART-8022, ART-1020, ARt-1021, ART-1023, ARt-1024, ART-1026, ART-1027, ART-1029, Acidified Tyrodes Solution 1060 Human Albumin 100 mg/ml in Normal Saline ART-3001, ART-3003 SupraSperm® 90, 100, SupraSperm® System SynVitro Hyadase 1513, 15135001 ORIGIO Handling medium 8310, 8311 UTM™ (with phenol red) 1052, (without phenol red) 1152 ICSI Cumulase® 1612 SAGE Vitrification and Warming kits ART-8025, ARt-8026, ART-8030, ART-8031, ART-8034 and ART-8035 ORIGIO® Sequential Blast 8305, 8306

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility