Shanghai Zhicheng Analytical Instruments
Penguji disolusi dan instrumen pengujian tablet untuk QC farmasi.
Shanghai Zhicheng memproduksi instrumen pengujian farmasi termasuk penguji disolusi, penguji disintegrasi, penguji kekerasan, dan penguji kerapuhan untuk laboratorium QC. Perusahaan mengekspor instrumen kendali mutu farmasi yang hemat biaya ke produsen obat generik di Asia dan Afrika.
- Type
- Manufacturer
- Location
- Shanghai, China
- Founded
- 2001
- Website
- shzc.cn
- Categories
- Perlengkapan Medis & Kesehatan
- Markets
- Tiongkok, India, Vietnam, Bangladesh, 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)