HistoIndex
Sistemas de imágenes de patología digitales sin manchas.
HistoIndex fabrica sistemas de imágenes de patología digitales sin manchas en sus operaciones de Singapur. La empresa suministra sistemas de atención médica, laboratorios, socios OEM o clientes de exportación regulados en sus mercados primarios listados.
- Type
- brand seeking distribution
- Location
- Singapore
- Founded
- 2010
- Website
- histoindex.com
- Categories
- Suministros médicos y sanitarios, Electrónica de consumo
- Markets
- Singapur, Estados Unidos, Alemania, Japón
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)