BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    40V033V495

    Reg #: 3003137205 · FEI: 3003137205 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    200
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Kreatech biotechnology b.v.
    Registration Number
    3003137205
    FEI Number
    3003137205
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Vlierweg 20
    City
    Amsterdam Noord-Holland
    Country
    NL

    Owner / Operator

    Firm Name
    KREATECH Biotechnology BV
    Operator Number
    10024575
    Address
    Vlierweg 20
    City
    Amsterdam
    State
    Noord-Holland
    Postal Code
    1032 LG
    Country
    NL
    Correspondent
    Adam Blunier

    US Agent

    Business Name
    Leica Biosystems, division of Leica Microsystems, Inc.
    Contact Name
    Adam Blunier
    Address
    21440 W. Lake Cook Road, Floor 5
    City
    Deer Park
    State
    IL
    ZIP
    60010
    Country
    US
    Email
    [email protected]
    Phone
    630 6340069 ext. 3462

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU

    Proprietary Names

    40V033V495 15C001C495 09Q004C415 01P003B550 KI-20009G SE7 (D7Z1)-007 - XL EWSR1 (22q12) Proximal - XL 03Q003B495 23P003C495 05P001I495 20Q003B550 07Q001C550 EWSR1 (22q12) Distal - XL 09P005B550 KI-20017B 06Q005B550 23P002C550 KI-20001G 06Q004D530 07C001B495 17C006B495 18Q003V495 SS18 (18q11) Distal - XL 08Q006B550 17C007V495 02P006B550 01P001I495 13Q001I550 KI-40002 08P004V550 23C004J495 KI-20009R 03Q007B550 03Q004B550 13Q002C415 11Q005I550 14Q001C495 02P009V550 06Q007V550 08Q008V550 03Q002B495 KI-40001 10Q007V495 03C001N415 KI-20015B KI-20008B FOXO1 (13q14) Distal - XL 05Q001B495 04Q003C550 12P001B495 10Q002B550 22Q002B550 06Q003B495 22Q001C495 40V000V495 08P002B550 24C004J550 21Q003I550 11Q003I495 KI-20011G KI-30004R 08Q001I550 17P001B550 DDIT3 (12q13) Distal - XL 03Q008B495 10C001N495 10C003C415 02P002B550 16Q001I495 22Q003B495 17P001I550 09Q003B495 06Q001A550 09P003B495 09C001J550 06Q002B495 18Q002B550 04Q001B550 07C006V495 11Q001I495 18C004J415 18Q004V550 KI-20006R SE12 (D12Z3)-002 - XL 17Q004V550 05Q002B550 KI-20018B 20Q003I550 06Q003B550 23C001B495 14Q005V495 01Q001I550 08C001B495 07C004D530 EGFR (7p11) - XL 13Q002C495 14Q004V550 17Q001I495 08P003B550 01P001B495 07C002I495 23C002J495 04Q005B550 04Q002C495 19P002B495 KI-20010R 04P001B495 11Q001B495 07C003C415 03Q006C415 KI-20023B CCND1 (11q13) Distal - XL 08C003V495 DDIT3 (12q13) Proximal - XL 40V006V495 13Q001C550 02P008V495 CCND1 (11q13) Proximal - XL 08P001B495 14Q001C415 01Q001B550 04C001B495 04C002C550 KI-20008R 04P001I495 03Q010V550 03Q005C495 15Q001I550 02P005B495 02P001B495 13Q003J550 12C001J495 21Q001I495 FUS (16p11) Proximal - XL 06Q006V495 17Q002B550 KI-20017G NTRK1 (1q23) Distal - XL KI-20011B 23P004C550 KI-20012R 08C002I495 08Q002I550 KI-20001R 40V011V495 FUS (16p11) Distal - XL 03Q009V495 NTRK1 (1q23) Proximal - XL 23P001B550 40V016V495 21Q002B550 KI-20012B 10Q008V550 40V031V495 20P001I495 07P001C495 40V000V000 09Q005C550 24C003J550 SS18 (18q11) Proximal - XL 19P003B550 KI-20006G 07Q004B550 04Q004C415 07C003J415 03Q001B550 08Q007V495 10Q001B495 09C001C550 13Q002J415 07Q004I550 07Q001B550 17P002V550 18C001J415 16Q001B495 12C001C495 14Q001I550 FOXO1 (13q14) Proximal - XL 24C002N415 15C001J495 16Q003I550 20P001B495 KI-20009B 11Q002I495 KI-20007B 05Q004I550 16Q002I495 09P004B550 KI-30001R 17C003C495 18Q001B495 03Q004C550 14Q001B550 MDM2 (12q15) - XL 20Q002B495 08Q005B495 13Q004I495 07Q002V550 40V018V495 13Q002I495

    Establishment Types

    Manufacture Medical Device