BEUDAMED
    EU Manufacturer ๐Ÿ‡บ๐Ÿ‡ธ United States Active

    Biochemical Diagnostics, Inc

    SRN: US-MF-000025179 ยท Heartland Blvd 180, 11717 Edgewood, United States
    View on EUDAMED
    Basic UDI-DIs
    173
    Total Devices
    173
    On Market
    173
    Off Market
    0
    Certificates
    0
    Valid
    0
    Expiring < 6mo
    0
    Countries
    32

    Basic Information

    Address
    Heartland Blvd 180, 11717 Edgewood, United States
    Email
    [email protected]
    Website
    www.kovaintl.com

    Regulatory Overview

    Regulation
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    Eu Ivdd 173
    Classification
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    Eu Ivd General 173
    Device Types
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    Certificate Health

    No certificates registered for this manufacturer.

    Market Presence

    Devices from this manufacturer are available in 32 countries across Europe.

    ๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡ฎ Liechtenstein ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia ๐Ÿ‡น๐Ÿ‡ท Tรผrkiye ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

    Device Portfolio

    Name
    9 PANEL -/+ 25%, 5ML KITBOX
    9 PANEL, CUTOFF, 5mL
    AU/NZ SKREEN, Cutoff +50%, 20mL
    AU/NZ SKREEN, Cutoff +50%, 5mL
    AU/NZ SKREEN, Cutoff -50%, 20mL
    AU/NZ SKREEN, Cutoff -50%, 5mL
    AUNZS19 Cutoff +50%, 20mL
    AUNZS19 Cutoff +50%, 5mL
    AUNZS19 Cutoff -50%, 20mL
    AUNZS19 Cutoff -50%, 5mL
    Buprenorphine 15ng/mL, 5mL
    Buprenorphine 5ng/mL, 5mL
    CONFIRM 3, +25%, 50mL
    CONFIRM 3, -60%, 50mL
    CONFIRM 3, CUTOFF, 50mL
    CONFIRM 3, Cutoff -25%, 50mL
    CONFIRM 4 CUTOFF -25%, 10x50mL
    CONFIRM 4, CUTOFF +25%, 10x50mL
    CONFIRM 4, Cutoff -60%, 10x50mL
    COTININE URINE CONTROL 2x5mL Kitbox
    CP-OF Panel, 3X Cutoff, 20mL
    CP-OF Panel, Cutoff +50%, 20mL
    CP-OF Panel, Cutoff -50%, 20mL
    CSCQ Specimen 1
    CSCQ Specimen 2
    CSCQ Specimen 3
    CSCQ Specimen 4
    Combo-A, 3X Cutoff, 20mL
    Combo-A, 3X Cutoff, 6x20mL
    Combo-A, Cutoff +50%, 20ml
    Combo-A, Cutoff +50%, 6x20mL
    Combo-A, Cutoff -50%, 20mL
    Combo-A, Cutoff -50%, 6x20mL
    Combo-H, +50%, 20ml
    Combo-H, 3X Cutoff, 20mL
    Combo-H, 3X Cutoff, 6x20mL
    Combo-H, Cutoff +50%, 6x20mL
    Combo-H, Cutoff -50%, 20mL
    Combo-H, Cutoff -50%, 6x20mL
    Combo-U, 3X Cutoff, 20mL
    Combo-U, 3X Cutoff, 6x20mL
    Combo-U, Cutoff +50%, 20mL
    Combo-U, Cutoff +50%, 6x20mL
    Combo-U, Cutoff -50%, 20mL
    Combo-U, Cutoff -50%, 6x20mL
    Confirm 4, Cutoff 10x50mL
    Cotinine, 5ml in baggie 400ng/ml
    Custom Oral Fluid, AU/NZ Cutoff +50%, 5mL
    Custom Oral Fluid, Negative, 5mL
    DOA SCREEN Cutoff +25% 6x20 mL pk
    View all 173 devices โ†’