Automatic Sample System Centrifuge - Vietnam Registration 230000796/PCBA-HCM
Access comprehensive regulatory information for Automatic Sample System Centrifuge in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loแบกi A medical device is registered under number 230000796/PCBA-HCM and manufactured by Andreas Hettich GmbH & Co. KG.
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Device Details
Registration Details
230000796/PCBA-HCM
000.00.19.H29-230613-0013
ROTANTA 460 Robotic
Technical Details
The ROTANTA 460 Robotic Centrifuge is a medical device for in vitro diagnosis, in compliance with the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. It is a device used to centrifuge and enrich human sample material for further processing for diagnostic purposes. The user can set each variable physical parameter within the limits of the device. The centrifuge can only be used by qualified personnel in controlled laboratories. The centrifuge is intended for the purpose mentioned above. The intended purpose also includes compliance with all instructions in the manual and compliance with the necessary work and maintenance. Any other use or misuse is considered inappropriate. Andreas Hettich GmbH & Co. KG will not be liable for any damage resulting from this. If the centrifuge is installed in another device or integrated into a system, the manufacturer of the entire system is responsible for its safety.
Dates and Status
Jun 22, 2023

