BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    IBL INTERNATIONAL GMBH

    Reg #: 9710337 · FEI: 3002676602 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    39
    Establishment Types
    4
    Classifications
    12

    Registration Details

    Registration Name
    IBL INTERNATIONAL GMBH
    Registration Number
    9710337
    FEI Number
    3002676602
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    FLUGHAFENSTRASSE, 52A
    City
    HAMBURG
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K040923

    Owner / Operator

    Firm Name
    Tecan Group AG
    Operator Number
    9050992
    Address
    103 Seestrasse, --
    City
    Maennedorf
    State
    Zurich
    Postal Code
    8708
    Country
    CH

    US Agent

    Business Name
    Tecan U.S.
    Contact Name
    Taunya Alexander
    Address
    9401 Globe Center Dr Ste 140
    City
    Morrisville
    State
    NC
    ZIP
    27560
    Country
    US
    Email
    [email protected]
    Phone
    919 5725421

    Products

    Device Name Product Code
    Radioimmunoassay, Progesterone JLS
    Radioimmunoassay, Estradiol CHP
    Enzyme Immunoassay, Cortisol, Salivary NHG
    Research Use Only/Immunology Devices OTR
    Calibrator, Secondary JIT
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Radioimmunoassay, 17-Hydroxyprogesterone JLX
    Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking NST
    General Purpose Reagent PPM

    Proprietary Names

    Progesterone Luminescence Immunoassay SaliCap 17beta-Estradiol Saliva Luminescence Immunoassay Cortisol Saliva Luminescence Immunoassay Anti-Muellerian Hormone (AMH) ELISA DEPROTEINIZATION INT.STD.SOL.LC-MS VITAE CA 72-4 ELISA CALIBRATOR SET IMMUNOSUPPRESANTS RUO CONTROL SET LC-MS PSYCHOT.MED. 2 RUO INTERNAL STD. D3 LC-MS VB1B6 10X6ML RUO CONTROL SET LC-MS PSYCHOT.MED. 1 RUO Human IL-6 ELISA Spermatozoa-Ab ELISA WASH BUFFER ELISA KITS 30ML 1VIAL CALIBRATOR SET LC-MS PSYCHOT.MED. 1 RUO CALIBRATOR SET LC-MS PSYCHOT.MED. 2 RUO Cardiolipin IgM ELISA Tec-Trace Metanephrines Control set ELISA PROINSULIN INTACT Testosterone Luminescence Immunoassay Unassayed Testosterone QC Material HYDROFLEX PLUS HYDROFLEX HYDROFLEX EVOLYZER 8CH HYDROFLEX EVOLYZER 16CH HYDROFLEX ELISA HYDROSPEED HYDROFLEX FREEDOM EVO 96PW PW384 COLUMBUS DHEA-S ELISA DHEA ELISA 17-OH-Progesterone ELISA (30223011) Acetylcholine Receptor Autoantibodies (ARAb) RRA Steroid Tuning Mix 4 Steroid Tuning Mix 1 Steroid Tuning Mix 2 Steroid Tuning Mix 3

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device