BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Roche Diabetes Care GmbH

    Reg #: 3011806823 · FEI: 3011806823 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    168
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    Roche Diabetes Care GmbH
    Registration Number
    3011806823
    FEI Number
    3011806823
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Sandhofer Strasse 116
    City
    Mannheim Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K214022

    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
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Accessories, Pump, Infusion MRZ
    Calculator/Data Processing Module, For Clinical Use JQP
    Calprotectin, Fecal NXO

    Proprietary Names

    Accu-Chek Softclix Blood Lancing System ACCU-CHEK 360 DIABETES MGMT 2.3 cobas transfer - RRF Heam,Coag 10 cobas bge link cobas Academy cobas IT 1000 c8100 PXT c8100 CLW c8100 TLJ c8100 SLL c8100 Type Alpha cobas 8100 OBS cobas 8100 ACU c8100 RFX c8100 Model Beta cobas 8100 connection kit cobas 8100 URF . c8100 SCM cobas 8100 RSF c8100 CLO Universal Connection Unit Bulk Loader for cobas p 471 Laser LLD centrifuge unit cobas connection module c8100 Beta c8100 SLR Aliquot Tip Loader cobas 8100 AOB c8100 CRW cobas 8100 BCL turn unit conveyor unit c8100 BCL cobas 8100 Model Alpha cobas 8100 BCL - FBT Modification kit cobas 8100 Signal Tower c8100 BRF Sorting System cobas p312(Kolibri) Bulk Loader Module for p512/612 LASER LLD INCL QSI/TTI cobas p501/p701 c8100 CRO Liquid Level Detection UPGR Kit cobas p701 cobas p 512 System Software cobas p 612 system cobas p671 output unit CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE cobas 8100 RSS Roche cobas Liat Module- IT 1000 Bi-directional driver STD INSTR P671 TTI W/O BC READ UN 115V p501/p701 Systems STD INSTR P471 TTI W/O BC READ UN 115 PComm ver 1.12.11 cobas Infinity v2.2.3 RSD Systems 770-1-CCM-AOB v1.1 VS Systems CCM AOB sw ver 13 cobas Infinity v2.3.3 SW COBAS P 312 VERSION 1.1.1 SW PATCH_P312_1.1.3_UPD.TAR.BZ2 STD INSTR P612 LASER LLD QSI REC w/o CCM Online Adapter 1.5 cobas Infinity v2.3.2 STD INSTR P671 TTI BC READING UN 115V cobas Infinity v2.2.1 COBAS P612 PRE-ANALYTICAL SYSTEM W/O CCM RSA Systems cobas8800B cobas p471 STD INSTR P471 TTI BC READING UNIT 115V cobas infinity sw v2.5.3 CLAS Systems cobas infinity MPA Systems cobas Infinity 3rd Party Drivers IT 1000 Operator Data driver ver. 1.1.2 HemoCue 201DM Glu RT module STD INSTR P612 LASER LLD QSI 3HHT CCM 713-2-cobase 8100 v1.5 CoaguChek Link Tier 1 cobas Infinity v2.2 IT 1000- PCOmmunicator .bat file 579-2-RSA Dynamic Interface v1.1 c8100 SW 03-09 cobas Infinity v2.2.2 c8100 Wright Patterson Air Force Base US cobas IT 1000 i-STAT/DE module HemoCue 201DM Glu module Coaguchek Link cobas infinity insights license PComm ver. 1.12.12 with script_1.12.13 MPA EVO Analycer connection Host CIT1k 3.9 CoaguChek Link Tier 2 Comm Server 1.11.3725 BCM for cobas 8100 Driver Framework 3.1.8915 Power Supply Unit cobas Infinity sw v2.5.1 cobas infinity POC IT solutions IT 1000 All in one installer STD INSTR P512 LASER LLD QSI REC w/o CCM cobas infinity core license cobas IT 1000 Operator Sync CoaguChek Link Tier 3 Piccolo Xpress module cobas p 501/ p 701 system software CCM cobas c 513 Connection Unit Linear Buffer Unit HemoCue 201DM Hb module cobas p 501/701 System Software CCM Address Extension Unit Data Innovations Instrument Manager Modular Connection Unit cobas infinity sw v317 Cobas 6000 Connection Unit CONVEYOR 2 Unit CONVEYOR 4 Unit SW c8000 data manager 168 HST Connection Unit Add-On Buffer Unit NAVIFY Remote Monitor OUTPUT UNIT Cobas 8000 Connection Unit CONVEYOR 3 Unit CONVEYOR 1 Unit CCM Bidirectional Interface TURN UNIT cobas Infinity Central Lab CCM Backend Connection Unit cobas 8100 System Software cobas BLIM for p471/p671/BCM cobas BLIM for p512/p612 ConKit cobas BLIM to p x71 B-Gate Interface cobas p 512 system cobas infinity POC CCM Vertical Overhead Conveyor Unit (1m) cobas transfer - RRF Urine 10 CD SYSTEM SW p 612 SP 2.1.1 navify® Lab Operations Accu-Chek Care cobas infinity POC remote access CCM Vertical Turntable Unit Accu-Chek 360° Diabetes Management System Professional CCM Vertical Power Box Unit Universal Connection Module (UCM2) CD SW multilingual_software_2.1.1 CD SYSTEM SW p 512 SP 2.1.1 navify POC Operations Accu-Chek Care (HCP) Kidney KFRE Algorithm navify Quality Control CCM Vertical Elevator Unit Accu-Chek Smart Pix Software cobas transfer - RRF Coag 5 cobas p 501 Post-Analytical Unit cobas p (701) POST ANALYTICAL Accu-Chek Fastclix Blood Lancing System fCAL turbo URCI fCAL Calibrator Set fCAL turbo CALEX® Cap fCal Control Set

    Establishment Types

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