MedtechSourcebook

EDWARDS LIFESCIENCES TECHNOLOGY SARL

Contract manufacturer ยท Anasco, PR

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2025Product codes first listed, by year (tallest: 1)2026
FDA registration
2648045 (openFDA record; or search FDA's registration database)
FEI number
2648045
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
Becton, Dickinson and Company (FDA owner/operator no. 10093301)
Registered address
STATE ROAD 402, KM 1.4, Industrial Park, Anasco, PR 00610
Contract listings
4 device listings, 2 product codes, first listed May 6, 2025
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
DYBIntroducer, CatheterClass IICardiovascularContract manufacturingMay 6, 2025
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysClass IIGeneral hospitalContract manufacturingFeb 13, 2026