Shanghai Zhicheng Analytical Instruments
用于制药质量控制的溶出度测试仪和片剂测试仪器。
上海志诚为QC实验室生产溶出度测试仪、崩解测试仪、硬度测试仪和脆碎度测试仪等药品测试仪器。该公司向亚洲和非洲的仿制药制造商出口具有成本效益的药品质量控制仪器。
- Type
- Manufacturer
- Location
- Shanghai, China
- Founded
- 2001
- Website
- shzc.cn
- Categories
- 医疗保健用品
- Markets
- 中国, 印度, 越南, 孟加拉国, 印度尼西亚
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)