Medline México S. de R.L. de C.V.
Manufaktur medis-bedah sekali pakai untuk pasar perawatan kesehatan Amerika Utara.
Pusat manufaktur Medline Industries di Meksiko yang memproduksi tirai bedah sekali pakai, gaun pelindung, peralatan prosedur, dan produk perawatan luka di fasilitas maquiladora di Ciudad Juárez; beroperasi di bawah registrasi FDA dan ISO 13485 QMS, mengekspor hampir semua output ke rumah sakit dan distributor layanan kesehatan AS.
- Type
- Manufacturer
- Location
- Juárez, Mexico
- Founded
- 2005
- Website
- medline.com
- Categories
- Perlengkapan Medis & Kesehatan, Perlengkapan Industri
- Markets
- Meksiko, Amerika Serikat, Kanada
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)