BEUDAMED
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    BSL-1065/G

    Device
    EU MDR · Eu Md Class 1 ·AGA Sanitätsartikel GmbH·On the market·32 countries

    Intermundien - Lemon Europe GmbH

    Authorized representative
    🇩🇪 Germany·11 Manufacturers·21 Devices

    Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG

    Manufacturer
    🇩🇪 Germany·855 Basic UDI-DIs·855 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

    Medprin Biotech GmbH

    Manufacturer
    🇩🇪 Germany·155 Basic UDI-DIs·154 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.

    NovaCutis GmbH

    Manufacturer
    🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    IBL International GmbH

    Manufacturer
    🇩🇪 Germany·23 Basic UDI-DIs·29 Devices·BSI Group The Netherlands B.V.

    RECIPE Chemicals + Instruments GmbH

    Manufacturer
    🇩🇪 Germany·74 Basic UDI-DIs·97 Devices·BSI Group The Netherlands B.V.

    exocad GmbH

    Manufacturer
    🇩🇪 Germany·8 Basic UDI-DIs·12 Devices·BSI Group The Netherlands B.V.

    orangedental GmbH & Co. KG

    Manufacturer
    🇩🇪 Germany·6 Basic UDI-DIs·7 Devices·BSI Group The Netherlands B.V.

    BSN medical GmbH

    Authorized representative
    🇩🇪 Germany·3 Manufacturers

    Dr. Kleine Pharma GmbH

    Manufacturer
    🇩🇪 Germany·16 Basic UDI-DIs·17 Devices·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and BSI Group The Netherlands B.V.

    BSB-Medical GmbH

    Importer
    🇩🇪 Germany

    BSN-Jobst GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·July 27, 2016

    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·December 6, 2017

    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·December 6, 2017

    N Latex CDT Kit

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·September 5, 2018

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·April 29, 2020

    HZ 1197161-1

    Certificate
    MDR QMS·BÖSL Medizintechnik GmbH·TÜV Rheinland LGA Products GmbH

    170771754

    Certificate
    MDD Annex II (excluding section 4)·BSC Medical Devices GmbH·DQS Medizinprodukte GmbH·11 Basic UDI-DIs