BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    PALM MEDICAL INTERNATIONAL BV

    Reg #: 3030626857 · FEI: 3030626857 · Expires 2026
    View on FDA
    Products
    46
    Proprietary Names
    26
    Establishment Types
    1
    Classifications
    46

    Registration Details

    Registration Name
    PALM MEDICAL INTERNATIONAL BV
    Registration Number
    3030626857
    FEI Number
    3030626857
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Broekstraat 65
    City
    Buggenhout Oost-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K991088

    Owner / Operator

    Firm Name
    PALM MEDICAL INTERNATIONAL BV
    Operator Number
    10090320
    Address
    Broekstraat 65
    City
    Buggenhout
    State
    Oost-Vlaanderen
    Postal Code
    9255
    Country
    BE
    Correspondent
    KOEN LUYPAERT

    US Agent

    Business Name
    ALLWAYS FORWARDING INTL
    Contact Name
    Vicky Mucksavage
    Address
    701 Newark Avenue
    City
    Elizabeth
    State
    NJ
    ZIP
    07208
    Country
    US
    Email
    [email protected]
    Phone
    908 3534000 ext. 2233

    Products

    Device Name Product Code
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Razor, Surgical LWK
    Syringe, Piston FMF
    Syringe, Antistick MEG
    Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling PNG
    Drape, Surgical, Exempt PUI
    Tube Tracheostomy And Tube Cuff JOH
    Drape, Surgical, Antimicrobial KKX
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    Indicator, Physical/Chemical Sterilization Process JOJ
    Retractor GAD
    Set, Administration, Intravascular FPA
    Warmer, Blood, Non-Electromagnetic Radiation BSB
    Speculum, Vaginal, Nonmetal HIB
    Respirator, Surgical MSH
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB
    Pneumoperitoneum Needle FHO
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Apparatus, Suction, Patient Care DWM
    Continuous Measurement Thermometer FLL
    Film, Radiographic IWZ
    Indicator, Biological Sterilization Process FRC
    Instrument, Biopsy KNW
    Needle, Hypodermic, Single Lumen FMI
    Container, Liquid Medication, Graduated KYW
    Anesthesia Conduction Kit CAZ
    Tape And Bandage, Adhesive KGX
    Ophthalmoscope, Ac-Powered HLI
    Stethoscope, Manual LDE
    Set, I.V. Fluid Transfer LHI
    Dressing, Wound, Occlusive NAD
    Anti Fog Solution And Accessories, Endoscopy OCT
    Laparoscope, General & Plastic Surgery GCJ
    Bag, Bile Collecting EXF
    Bandage, Cast ITG
    Otoscope ERA
    Stethoscope, Electronic DQD
    Slides, Microscope KEW
    Container, Specimen Mailer And Storage, Temperature Controlled, Sterile KDW
    Dressing, Wound, Hydrophilic NAC
    Electrode, Electrocardiograph DRX
    Guard, Instrument LXZ
    Biopsy Needle FCG
    Needle, Aspiration And Injection, Disposable GAA
    Tube, Tracheostomy (W/Wo Connector) BTO
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Tubes, vials, systems, serum separators, blood collection Syringe, piston Peritoneal, drainage catheter for refractory ascites, long-term indwelling Tube tracheostomy and tube cuff steridrape Needle, conduction, anesthetic (w/wo introducer) RETRACTOR Speculum, vaginal, nonmetal pneumoperitoneum needle APPARATUS, SUCTION, PATIENT CARE Catheter, intravascular, therapeutic, short-term less than 30 days Syringe, antistick CONTAINER, LIQUID MEDICATION, GRADUATED Anesthesia conduction kit Needle, hypodermic, single lumen Needele, hypodermic, single lumen Set, administration, intravascual Thermometer, electronic, clinical Anti fog solution and accessories, endoscopy GCJ - Laparoscope, general & plastic surgery Indicator, biological sterilization process Set, i.V. Fluid transfer CONTAINER, SPECIMEN MAILER AND STORAGE, TEMPERATURE CONTROLLED, STERILE Biopsy needle Set, administration, intravascular Tube, tracheostomy (w/wo connector) Electrosurgical, cutting & coagulation & accessories

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device