BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Primo Medical Group, Inc

    Reg #: 3009420598 · FEI: 3009420598 · Expires 2026
    View on FDA
    Products
    53
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    53

    Registration Details

    Registration Name
    Primo Medical Group, Inc
    Registration Number
    3009420598
    FEI Number
    3009420598
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    375 West St
    City
    W Bridgewater
    State
    MA
    ZIP
    02379
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120086

    Owner / Operator

    Firm Name
    Primo Medical Group, Inc
    Operator Number
    9004401
    Address
    75 Mill Street
    City
    Stoughton
    State
    MA
    Postal Code
    02072
    Country
    US

    Products

    Device Name Product Code
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Tubing, Noninvasive GAZ
    Bottle, Collection, Breathing System (Calibrated) CBD
    Colonoscope And Accessories, Flexible/Rigid FDF
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Laryngoscope, Non-Rigid CAL
    Drape, Adhesive, Aerosol KGT
    Mesh, Surgical, Deployment Balloon OQL
    Mesh, Surgical, Polymeric FTL
    Laparoscope, General & Plastic Surgery GCJ
    Hyperthermia Monitor NZE
    Endoscopic Irrigation/Suction System OCX
    System, Suction, Lipoplasty MUU
    Lubricant, Patient KMJ
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Instrument, Surgical, Non-Powered HAO
    Ophthalmic Femtosecond Laser OOE
    Laparoscope, Gynecologic (And Accessories) HET
    Hook, Surgical, General & Plastic Surgery GDG
    Neurological Tray OJG
    Tubing And Tubing/Filter Fits NVT
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Motor, Drill, Electric HBC
    Retractor, Self-Retaining, For Neurosurgery GZT
    Urethrotome EZO
    Lithotriptor, Ultrasonic FEO
    Electrode, Electrosurgical, Active, Urological FAS
    Introducer, Catheter DYB
    Catheter, Steerable DRA
    Bronchoscope (Flexible Or Rigid) EOQ
    Retractor GAD
    Catheter, Septostomy DXF
    Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
    Illuminator, Fiberoptic, Surgical Field HBI
    Light, Surgical, Fiberoptic FST
    Container, Specimen, Sterile FMH
    System, Suction, Lipoplasty For Removal QPB
    Instrument, Manual, Surgical, General Use MDM
    Instrument, Microsurgical GZX
    Esthesiometer, Ocular HJC
    Mitral Valve Repair Devices NKM
    Syringe, Irrigating (Non Dental) KYZ
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Joint, Knee, External Brace ITQ
    Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) HIN
    Regulator, Temperature JRR
    Hysteroscope (And Accessories) HIH
    Laryngoscope, Rigid CCW
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT
    Prosthesis, Mitral Valve, Percutaneously Delivered NPU
    Endoscope, Neurological GWG

    Proprietary Names

    Vapotherm FELIX-1 Nico BrainPath Approach Procedure Pack (International OUS) Nico BrainPath Approach Procedure Pack (Domestic US) Karl Storz Electrode Dexterity Steerable Introducer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device