MedtechSourcebook

CARDIONET, LLC

Contract manufacturer · Linwood, PA

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

FDA registration
3016812424 (openFDA record; or search FDA's registration database)
FEI number
3016812424
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Contract manufacturer
Owner or operator
Philips Medical Systems International BV (FDA owner/operator no. 1217116)
Registered address
600 West Ridge Road, Linwood, PA 19061
Contract listings
4 device listings, 4 product codes, first listed Nov 12, 2003
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
DRXElectrode, ElectrocardiographClass IICardiovascularContract manufacturingFeb 23, 2022
DSHRecorder, Magnetic Tape, MedicalClass IICardiovascularContract manufacturingNov 6, 2023
DSIDetector And Alarm, ArrhythmiaClass IICardiovascularContract manufacturingNov 6, 2023
IKDCable, ElectrodeClass IIPhysical medicineContract manufacturingNov 12, 2003

Other contract facilities of Philips Medical Systems International BV