Shandong Weigao Group Medical Polymer Co., Ltd.
中国最大的一次性医疗用品制造商：输液器、血袋、手术手套和骨科植入物。
威高集团是中国最大的一次性医用聚合物制造商，生产静脉输液器、采血系统、手术手套、骨科脊柱和关节植入物以及骨水泥。该集团运营专门的 Stryker 和 Becton Dickinson 合资设施，并通过其上市的 MedTech 子公司向 100 多个国家出口。
- Type
- Manufacturer
- Location
- Weihai, China
- Founded
- 1991
- Website
- weigaogroup.com
- Categories
- 医疗保健用品, 包装及印刷用品
- Markets
- 中国, 印度, 美国, 德国, 巴西
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality 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)
- Paper and printed products imported into the EU fall under the Deforestation Regulation (EUDR) due-diligence regime. European Commission (EUDR)