Shanghai Zhicheng Analytical Instruments
Probadores de disolución e instrumentos de prueba de tabletas para control de calidad farmacéutico.
Shanghai Zhicheng fabrica instrumentos de pruebas farmacéuticas, incluidos probadores de disolución, probadores de desintegración, probadores de dureza y probadores de friabilidad para laboratorios de control de calidad. La empresa exporta instrumentos rentables de control de calidad farmacéutica a fabricantes de medicamentos genéricos en Asia y África.
- Type
- Manufacturer
- Location
- Shanghai, China
- Founded
- 2001
- Website
- shzc.cn
- Categories
- Suministros médicos y sanitarios
- Markets
- China, India, Vietnam, Bangladés, Indonesia
Claimed certifications
- ISO 9001, Quality Management 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)