Data / Medical devices / Germany / Roche Diabetes Care GmbH
Roche Diabetes Care GmbH: FDA-registered device maker in Mannheim Baden-Wurttemberg, Germany, 5 510(k) clearances
Roche Diabetes Care GmbH is registered with the FDA (registration 3011806823) in Mannheim Baden-Wurttemberg, Germany. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 13, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011806823
- Address
- Sandhofer Strasse 116, Mannheim Baden-Wurttemberg, Germany, 68305
- Owner or operator
- Roche Diagnostics Operations Inc. (9039767)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- June 12, 2008
- Registered through
- 2027
- Brand names listed
- 579-2-RSA Dynamic Interface v1.1, 713-2-cobase 8100 v1.5, 770-1-CCM-AOB v1.1, ACCU-CHEK 360 DIABETES MGMT 2.3, ACCU-CHEK SAFE-T-PRO PLUS 200CT 6/CASE, Accu-Chek 360° Diabetes Management System Professional, Accu-Chek Care, Accu-Chek Care (HCP) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Manufacturer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Calprotectin, Fecal | NXO | 2 | Exporter to the US | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 13, 2023 | K232488 | Accu-Chek Safe-T-Pro Plus Lancing Device | FMK | Substantially Equivalent | Roche Diabetes Care, Inc. | accessdata.fda.gov |
| April 29, 2022 | K220608 | Accu-Chek FastClix Blood Lancing System | QRL | Substantially Equivalent | Roche Diabetes Care, Inc. | accessdata.fda.gov |
| February 17, 2022 | K214022 | Accu-Chek Softclix Blood Lancing System | QRL | Substantially Equivalent | Roche Diabetes Care, Inc. | accessdata.fda.gov |
| September 24, 2019 | K191718 | Buhlmann fCAL turbo and CALEX Cap | NXO | Substantially Equivalent | Buhlmann Laboratories AG | accessdata.fda.gov |
| May 15, 2008 | K080227 | ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM | MRZ | Substantially Equivalent | Roche Diagnostics Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Accessories, Pump, Infusion
- All makers of Calprotectin, Fecal
Updated November 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.