Roche Diagnostics
Roche Diagnostics, dont le siège est à Rotkreuz/Bâle, est le leader mondial du diagnostic in vitro…
Roche Diagnostics, dont le siège est à Rotkreuz/Bâle, est le leader mondial du diagnostic in vitro, fabriquant des glucomètres, des analyseurs d'immunoessais, des équipements de test PCR et des réactifs de diagnostic. La fabrication suisse et la distribution mondiale fournissent aux hôpitaux, aux laboratoires cliniques et aux distributeurs de diagnostic dans plus de 100 pays des dispositifs médicaux homologués CE/FDA.
- Type
- brand seeking distribution
- Location
- Rotkreuz, Switzerland
- Founded
- 1896
- Website
- roche.com
- Categories
- Fournitures médicales et de santé
- Markets
- États-Unis, Allemagne, Japon, Royaume-Uni, Chine
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)