Shandong Weigao Group Medical Polymer Co., Ltd.
Pembuat pasokan medis sekali pakai terbesar di Tiongkok: set infus, kantong darah, sarung tangan bedah, dan implan ortopedi.
Weigao Group adalah produsen polimer medis sekali pakai terbesar di Tiongkok, yang memproduksi set infus intravena, sistem pengumpulan darah, sarung tangan bedah, implan tulang belakang dan sendi ortopedi, serta semen tulang. Grup ini mengoperasikan fasilitas JV khusus Stryker dan Becton Dickinson dan mengekspor ke lebih dari 100 negara melalui anak perusahaan MedTech yang terdaftar.
- Type
- Manufacturer
- Location
- Weihai, China
- Founded
- 1991
- Website
- weigaogroup.com
- Categories
- Perlengkapan Medis & Kesehatan, Perlengkapan Pengemasan & Percetakan
- Markets
- Tiongkok, India, Amerika Serikat, Jerman, Brasil
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)