Fresenius Kabi Philippines, Inc.
Infusion and clinical nutrition device manufacturer, producing IV sets and enteral feeding products.
Fresenius Kabi's Philippine facility assembles intravenous administration sets and feeding tubes for the Asia-Pacific market. The plant adheres to strict medical device quality systems and exports to hospital networks in the region.
- Type
- brand seeking distribution
- Location
- Cavite, Philippines
- Website
- fresenius-kabi.com.ph
- Categories
- Medical & Healthcare Supplies
- Markets
- Japan, Australia, New Zealand, Singapore, Malaysia
Verified facts
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- lei-lapsed (amber), checked 2026-08-30 GLEIF global LEI register (golden copy)
Claimed certifications
- ISO 13485, Medical Devices Quality 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)