Medline México S. de R.L. de C.V.
面向北美医疗保健市场的医疗外科一次性用品制造。
Medline Industries 的墨西哥制造中心在华雷斯城的加工工厂生产一次性手术巾、手术服、手术套件和伤口护理产品；在 FDA 注册和 ISO 13485 QMS 下运营，几乎所有产品都出口到美国医院和医疗保健分销商。
- Type
- Manufacturer
- Location
- Juárez, Mexico
- Founded
- 2005
- Website
- medline.com
- Categories
- 医疗保健用品, 工业用品
- Markets
- 墨西哥, 美国, 加拿大
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- FDA Registered FDA Establishment Registration
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)