BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    CCM Vertical Overhead Conveyor Unit (1m)

    Reg #: 9610126 · FEI: 3002806559 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    159
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ROCHE DIAGNOSTICS GMBH
    Registration Number
    9610126
    FEI Number
    3002806559
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SANDHOFER STRASSE 116
    City
    MANNHEIM Baden-Wurttemberg
    Country
    DE

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US

    US Agent

    Business Name
    Roche Diagnostics Operations Inc
    Contact Name
    Brian Frazier
    Address
    9115 Hague Rd
    City
    Indianapolis
    State
    IN
    ZIP
    46256
    Country
    US
    Email
    [email protected]
    Phone
    317 5214603

    Products

    Device Name Product Code
    Calculator/Data Processing Module, For Clinical Use JQP

    Proprietary Names

    CCM Vertical Overhead Conveyor Unit (1m) cobas transfer - RRF Heam,Coag 10 cobas transfer - RRF Coag 5 CCM Vertical Power Box Unit Accu-Chek 360° Diabetes Management System Professional navify Quality Control cobas IT 1000 cobas bge link cobas 8100 connection kit c8100 PXT c8100 Type Alpha c8100 Beta Universal Connection Unit c8100 CRW c8100 CLW cobas 8100 Model Alpha cobas 8100 AOB cobas 8100 BCL - FBT Modification kit c8100 Model Beta cobas 8100 OBS c8100 CLO c8100 TLJ c8100 BRF cobas Academy cobas 8100 ACU Bulk Loader for cobas p 471 c8100 RFX cobas 8100 Signal Tower Liquid Level Detection UPGR Kit cobas 8100 RSF Sorting System cobas p312(Kolibri) cobas 8100 URF . c8100 SLL c8100 SLR Laser LLD conveyor unit Aliquot Tip Loader cobas p501/p701 c8100 CRO cobas 8100 BCL c8100 BCL cobas p 512 System Software CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE output unit cobas p701 Bulk Loader Module for p512/612 c8100 SCM centrifuge unit LASER LLD INCL QSI/TTI turn unit cobas p671 cobas connection module cobas 8100 RSS STD INSTR P471 TTI BC READING UNIT 115V cobas Infinity v2.2.2 cobas Infinity v2.2.3 cobas p 612 system SW PATCH_P312_1.1.3_UPD.TAR.BZ2 579-2-RSA Dynamic Interface v1.1 RSD Systems 713-2-cobase 8100 v1.5 RSA Systems STD INSTR P671 TTI W/O BC READ UN 115V MPA Systems Roche cobas Liat Module- IT 1000 Bi-directional driver SW COBAS P 312 VERSION 1.1.1 cobas p471 cobas8800B MPA EVO Analycer connection Coaguchek Link PComm ver 1.12.11 cobas Infinity v2.2.1 cobas infinity insights license 770-1-CCM-AOB v1.1 IT 1000 All in one installer STD INSTR P471 TTI W/O BC READ UN 115 p501/p701 Systems STD INSTR P612 LASER LLD QSI REC w/o CCM Driver Framework 3.1.8915 CCM AOB sw ver 13 c8100 Wright Patterson Air Force Base US STD INSTR P671 TTI BC READING UN 115V BCM for cobas 8100 COBAS P612 PRE-ANALYTICAL SYSTEM W/O CCM CoaguChek Link Tier 3 cobas Infinity v2.2 VS Systems CLAS Systems Comm Server 1.11.3725 CoaguChek Link Tier 1 STD INSTR P612 LASER LLD QSI 3HHT CCM cobas infinity POC IT solutions IT 1000 Operator Data driver ver. 1.1.2 cobas Infinity 3rd Party Drivers cobas Infinity v2.3.3 cobas IT 1000 i-STAT/DE module cobas infinity Online Adapter 1.5 NAVIFY Remote Monitor cobas Infinity v2.3.2 CoaguChek Link Tier 2 cobas infinity core license IT 1000- PCOmmunicator .bat file Host CIT1k 3.9 cobas p 501/701 System Software Power Supply Unit SW c8000 data manager 168 Piccolo Xpress module HemoCue 201DM Glu RT module CCM Backend Connection Unit HST Connection Unit cobas infinity sw v2.5.3 CONVEYOR 3 Unit TURN UNIT Modular Connection Unit cobas Infinity sw v2.5.1 cobas 8100 System Software CONVEYOR 1 Unit Cobas 8000 Connection Unit HemoCue 201DM Glu module HemoCue 201DM Hb module CONVEYOR 2 Unit PComm ver. 1.12.12 with script_1.12.13 Cobas 6000 Connection Unit cobas IT 1000 Operator Sync CCM cobas c 513 Connection Unit c8100 SW 03-09 Data Innovations Instrument Manager cobas infinity sw v317 Add-On Buffer Unit cobas Infinity Central Lab STD INSTR P512 LASER LLD QSI REC w/o CCM cobas p 501/ p 701 system software Linear Buffer Unit OUTPUT UNIT CCM Bidirectional Interface CONVEYOR 4 Unit CCM Address Extension Unit ConKit cobas BLIM to p x71 cobas p 512 system cobas BLIM for p512/p612 CD SYSTEM SW p 612 SP 2.1.1 navify POC Operations cobas infinity POC cobas infinity POC remote access B-Gate Interface CCM Vertical Elevator Unit navify® Lab Operations cobas p 501 Post-Analytical Unit cobas transfer - RRF Urine 10 CCM Vertical Turntable Unit Accu-Chek Smart Pix Software Accu-Chek Care (HCP) CD SYSTEM SW p 512 SP 2.1.1 Kidney KFRE Algorithm cobas BLIM for p471/p671/BCM CD SW multilingual_software_2.1.1 cobas p (701) POST ANALYTICAL Accu-Chek Care

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device