BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    NZ BIOMED LIMITED

    Reg #: 3042172882 · FEI: 3042172882 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    NZ BIOMED LIMITED
    Registration Number
    3042172882
    FEI Number
    3042172882
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    59 Prospect Bank
    City
    Dunedin Otago
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K131780

    Owner / Operator

    Firm Name
    NZ Biomed Limited
    Operator Number
    10094475
    Address
    59 Prospect Bank
    City
    Dunedin
    State
    Otago
    Postal Code
    9010
    Country
    NZ
    Correspondent
    Nicola Kidd

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Colonoscope And Accessories, Flexible/Rigid FDF
    Endoscope, Accessories, Narrow Band Spectrum NWB
    Gastroscope And Accessories, Flexible/Rigid FDS
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Accessories, Cleaning, For Endoscope FEB
    Bronchoscope (Flexible Or Rigid) EOQ
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    System, X-Ray, Tomography, Computed JAK
    Microscope, Surgical, General & Plastic Surgery FSO
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Enteroscope And Accessories FDA
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Ultrasound Bronchoscope PSV

    Proprietary Names

    GIF-HQ190 TJF-Q190V BF-P190 GF-UCT180 BF-H190 BF-1TH190 SOMATOM Definition Edge Zeiss OPMI PROergo and accessories GF-UE160-AL5 GIF-XP190N BF-MP190F SIF-Q180 MAJ-2056 GIF-1TH190 CF-HQ190L

    Establishment Types

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