Bruker Daltonics GmbH & Co. KG
DE-MF-000024392 · Germany · Bremen
Bruker Daltonics GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 46 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: AST-Reagent Kit, Iron-depleted CAMHB, MALDI Biotyper sirius IVD System, MBT HT Mycobacteria IVD Module, MBT HT STAR-BL IVD Module.
Devices declared under this manufacturer
- AST-Reagent Kit
- Iron-depleted CAMHB
- MALDI Biotyper sirius IVD System
- MALDI Biotyper-BD sirius one IVD System
- MBT HT Mycobacteria IVD Module
- MBT HT STAR-BL IVD Module
- MBT STAR-Carba IVD Kit
- MICRONAUT-H Medium
- MICRONAUT-RPMI-1640 Medium + MOPS + Glucose
- MICRONAUT-S Pseudomonas MIC
- MICRONAUT-S ß-Lactamases
- MICRONAUT-SB Medium
Showing 12 of 46 declared devices.
Catalogue references include 1877012, 1890112, 1894123, E1-111-040, E2-319-100, E2-323-001.
European nomenclature codes declared: W0104010206, W02039092, W0104080107, W0104080501, W05030380, W020303.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Bruker Daltonics (DE) · FDA 3010191749 |
| Devices in EUDAMED | 46 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 46 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. Bruker Daltonics GmbH & Co. KG is registered in the United States but was not found in the Canadian register.