HistoIndex
Systèmes d’imagerie numérique de pathologie sans taches.
HistoIndex fabrique des systèmes d'imagerie numérique de pathologie sans taches à partir de ses opérations de Singapour. La société fournit des systèmes de santé, des laboratoires, des partenaires OEM ou des clients exportateurs réglementés sur ses principaux marchés cotés.
- Type
- brand seeking distribution
- Location
- Singapore
- Founded
- 2010
- Website
- histoindex.com
- Categories
- Fournitures médicales et de santé, Électronique grand public
- Markets
- Singapour, États-Unis, Allemagne, Japon
Verified facts
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)