HistoIndex
Sistemas de imagem digital de patologia sem manchas.
A HistoIndex fabrica sistemas de imagem digital de patologia sem manchas em suas operações em Cingapura. A empresa fornece sistemas de saúde, laboratórios, parceiros OEM ou clientes de exportação regulamentados em seus principais mercados listados.
- Type
- Manufacturer
- Location
- Singapore
- Founded
- 2010
- Website
- histoindex.com
- Categories
- Suprimentos médicos e de saúde, Eletrônicos de consumo
- Markets
- Singapura, Estados Unidos, Alemanha, Japão
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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)