Roche Diagnostics
Roche Diagnostics, headquartered in Rotkreuz/Basel, is the world's leading in vitro diagnostics c…
Roche Diagnostics, headquartered in Rotkreuz/Basel, is the world's leading in vitro diagnostics company, manufacturing blood glucose monitors, immunoassay analysers, PCR testing equipment, and diagnostic reagents. Swiss manufacturing and global distribution supply hospitals, clinical laboratories, and diagnostic distributors in 100+ countries with CE/FDA-cleared medical devices.
- Type
- brand seeking distribution
- Location
- Rotkreuz, Switzerland
- Founded
- 1896
- Website
- roche.com
- Categories
- Medical & Healthcare Supplies
- Markets
- United States, Germany, Japan, United Kingdom, 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)