Palex Medical S.A.
Palex Medical is a Spanish manufacturer and distributor of medical devices focusing on infusion t…
Palex Medical is a Spanish manufacturer and distributor of medical devices focusing on infusion therapy, critical care, and interventional cardiology products. The company manufactures its own line of IV sets, infusion pumps, and patient monitoring accessories, and also distributes internationally sourced medical devices to hospitals and clinics across Spain and Portugal. Palex has established a niche in single-use surgical instruments and neurology devices.
- Type
- Manufacturer
- Location
- Sant Cugat del Vallès, Spain
- Founded
- 1969
- Website
- palex.es
- Categories
- Medical & Healthcare Supplies
- Markets
- Spain, Portugal, France, Italy, Germany, United Kingdom, Mexico
Verified facts
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management 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)