Shanghai Zhicheng Analytical Instruments
Oplostesters en tablettestinstrumenten voor farmaceutische QC.
Shanghai Zhicheng produceert farmaceutische testinstrumenten, waaronder oplossingstesters, desintegratietesters, hardheidstesters en brosheidstesters voor QC-laboratoria. Het bedrijf exporteert kosteneffectieve farmaceutische kwaliteitscontrole-instrumenten naar fabrikanten van generieke geneesmiddelen in Azië en Afrika.
- Type
- Manufacturer
- Location
- Shanghai, China
- Founded
- 2001
- Website
- shzc.cn
- Categories
- Medische en gezondheidszorgbenodigdheden
- Markets
- China, India, Vietnam, Bangladesh, Indonesië
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)