Roche Diagnostics
Roche Diagnostics, con sede en Rotkreuz/Basilea, es el centro de diagnóstico in vitro líder en el mundo...
Roche Diagnostics, con sede en Rotkreuz/Basilea, es la empresa de diagnóstico in vitro líder en el mundo y fabrica monitores de glucosa en sangre, analizadores de inmunoensayo, equipos de prueba de PCR y reactivos de diagnóstico. La fabricación suiza y la distribución global suministran a hospitales, laboratorios clínicos y distribuidores de diagnóstico en más de 100 países dispositivos médicos aprobados por CE/FDA.
- Type
- brand seeking distribution
- Location
- Rotkreuz, Switzerland
- Founded
- 1896
- Website
- roche.com
- Categories
- Suministros médicos y sanitarios
- Markets
- Estados Unidos, Alemania, Japón, Reino Unido, China
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- registered-manufacturer (green), checked 2026-08-21 Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices
- operating-permit (green), checked 2025-06-24 SHAB, Swiss Official Gazette of Commerce
- fda-registered (green), checked 2026-07-21 FDA
- sanctions-clear (green), checked 2026-07-21 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)