MedtechSourcebook

Philips Ultrasound LLC

Contract manufacturer · Reedsville, PA

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

FDA registration
2518586 (openFDA record; or search FDA's registration database)
FEI number
2518586
Registered for
FDA registration year 2026
Establishment types
Specification developer; Manufacturer; Contract manufacturer
Owner or operator
Philips Medical Systems International BV (FDA owner/operator no. 1217116)
Registered address
1 Echo Dr, Reedsville, PA 17084
Contract listings
1 device listings, 4 product codes, first listed Aug 4, 2026
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
ITXTransducer, Ultrasonic, DiagnosticClass IIRadiologyContract manufacturingAug 4, 2026
IYNSystem, Imaging, Pulsed Doppler, UltrasonicClass IIRadiologyContract manufacturingAug 4, 2026
IYOSystem, Imaging, Pulsed Echo, UltrasonicClass IIRadiologyContract manufacturingAug 4, 2026
QIHAutomated Radiological Image Processing SoftwareClass IIRadiologyContract manufacturingAug 4, 2026

Other contract facilities of Philips Medical Systems International BV