Roche Diagnóstica Brasil Ltda.
In vitro diagnostics and clinical analyzers
Roche's Brazilian diagnostics division produces clinical chemistry and immunoassay reagents, as well as assembling automated analyzers. The company serves laboratories throughout Latin America.
- Type
- Manufacturer
- Location
- São Paulo, Brazil
- Founded
- 1945
- Website
- https://www.roche.com.br
- Categories
- Medical & Healthcare Supplies
- Markets
- Brazil, Argentina, Mexico
Verified facts
- web-presence-since (green), checked 2026-08-04 Internet Archive (Wayback)
- sanctions-clear (green), checked 2026-08-25 OpenSanctions
- debarment-clear (green), checked 2026-08-25 OpenSanctions
- domain-registered (green), checked 2026-08-25 Domain registry record
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- Good Manufacturing Practice
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)