BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Eurofins Infinity Laboratory Group Inc.

    Reg #: 3013944123 · FEI: 3013944123 · Expires 2026
    View on FDA
    Products
    34
    Proprietary Names
    48
    Establishment Types
    1
    Classifications
    34

    Registration Details

    Registration Name
    Eurofins Infinity Laboratory Group Inc.
    Registration Number
    3013944123
    FEI Number
    3013944123
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1836 Stone Ave
    City
    San Jose
    State
    CA
    ZIP
    95125
    Country
    US

    Owner / Operator

    Firm Name
    Eurofins - Infinity Laboratory Group Inc.
    Operator Number
    10080298
    Address
    1836 Stone Ave
    City
    San Jose
    State
    CA
    Postal Code
    95125
    Country
    US
    Correspondent
    Jennifer Eagan

    Products

    Device Name Product Code
    Shunt, Central Nervous System And Components JXG
    Device, Monitoring, Intracranial Pressure GWM
    Catheter, Percutaneous DQY
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Device, Surgical, Cryogenic GXH
    Stimulator, Nerve ETN
    Prosthesis, Intervertebral Disc MJO
    Prosthesis, Chin, Internal FWP
    Implant, Malar LZK
    Platelet And Plasma Separator For Bone Graft Handling ORG
    Device, Neurovascular Embolization HCG
    Device, Vascular, For Promoting Embolization KRD
    Hysteroscope (And Accessories) HIH
    Transducer, Ultrasonic, Diagnostic ITX
    Fluid Jet Removal System PZP
    Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia QKA
    Temporary Carotid Catheter For Embolic Capture NTE
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Esophagoscope (Flexible Or Rigid) EOX
    Catheter, Percutaneous, Neurovasculature QJP
    Arthroscope HRX
    Laparoscope, General & Plastic Surgery GCJ
    Catheter, Intravascular Occluding, Temporary MJN
    Catheter, Ultrasound, Intravascular OBJ
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Oximeter, Tissue Saturation MUD
    Interventional Fluoroscopic X-Ray System OWB
    Gastroscope And Accessories, Flexible/Rigid FDS
    Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction KKY
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence QPT
    Colonoscope And Accessories, Flexible/Rigid FDF
    Peripheral Mechanical Thrombectomy With Aspiration QEW

    Proprietary Names

    Device, Monitoring, intracranial pressure Shunt, central nervous system and components EagleRay, MantaRay, and StingRay families endoscopic access overtube, gastroenterology-urology RhinAer Stylus-CAT821 ETN, GXH - PACIRA Cervical/Lumbar Device M6 Product Family - Spinal Kinetics (Orthofix) PureForm-Surgiform Royal Biologics IOVERA Device Neurovascular embolization Artio Medical Silicone-Surgiform CellFX Percutaneous Electrode - Pulse Vivaer Stylus-CAT723 Electrosurgical, cutting & coagulation & accessories Platelet And Plasma Separator For Bone Graft Handling IRRAS MAKO 7 Procept BioRobotics-HYDROS Robotic system, Handpiece & TRUS Probe Urocross Expander System - Prodeon Medical Catheter, Angioplasty, peripheral, transluminal Catheter, angioplasty, peripheral,transluminal Lucid Diagnostics KAI MEDTECH LLC InSeca ARC Stylus CAT409 Arthroscope MIDAScope And Introducer Kit, And MidaSystem Sniper Infusion Catheter with Ballon Occlusion CarpX-PAVmed Intravascular Catheter - Provisio Vivaer ARC Stylus-CAT410 IRRAflow Catheter, IRRAflow tube set, IRRAflow Control Unit T-Stat Ischemia Monitor and sensors Bolt Navigation Case 1919-DWG-400 - CIRCINUS MEDICAL TECHNOLOGY, LLC PolarCath Peripheral Dilatation system Neptune-Pathfinder Endoscope Overtube Balloon Pathfinder Endoscope Overtube Gen 2 - Neptune medical Prodeon Urethral Sheath System - Prodeon Medical Suction Adaptor - Neptune Medical SFAM-Surgiform FLASH Flex™ Aorto-Ostial Angioplasty System Saf-T-Vac-Surgiform Valencia Technologies EsoCheck CCD-Lucid Diagnostics Stimulator, Nerve-Checkpoint Guardian Pathfinder® Endoscope Cap PulseBiosciences Harmony Catheter & Harmony Twist Units - Truvic Medical Inc.

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)