MedtechSourcebook

RR DONNELLEY-SUPPLY CHAIN SOLUTIONS

Contract manufacturer · Plover, WI

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

FDA registration
3006371704 (openFDA record; or search FDA's registration database)
FEI number
3006371704
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer; Repackager or relabeler
Owner or operator
RRDonnelley (FDA owner/operator no. 9077726)
Registered address
1600 DISK DR., Plover, WI 54467
Contract listings
36 device listings, 17 product codes, first listed Sep 19, 2005
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
CAZAnesthesia Conduction KitClass IIAnesthesiologyContract manufacturingSep 28, 2012
DPSElectrocardiographClass IICardiovascularContract manufacturingJun 19, 2024
DXHTransmitters And Receivers, Electrocardiograph, TelephoneClass IICardiovascularContract manufacturingJun 16, 2025
JINNitroprusside, Ketones (Urinary, Non-Quant.)Class IClinical chemistryContract manufacturingSep 26, 2012
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Class IClinical chemistryContract manufacturingSep 26, 2012
JQPCalculator/Data Processing Module, For Clinical UseClass IClinical chemistryContract manufacturingAug 30, 2013
LFRGlucose Dehydrogenase, GlucoseClass IIClinical chemistryContract manufacturingSep 19, 2005
MDSSensor, Glucose, InvasiveClass IIIClinical chemistryContract manufacturingOct 10, 2016
NBWSystem, Test, Blood Glucose, Over The CounterClass IIClinical chemistryContract manufacturingSep 19, 2005
OZOAutomated Insulin Dosing , Threshold SuspendClass IIIClinical chemistryContract manufacturingApr 24, 2020
OZPAutomated Insulin Dosing Device System, Single Hormonal ControlClass IIIClinical chemistryContract manufacturingApr 24, 2020
PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-InitiatedClass IIIClinical chemistryContract manufacturingOct 12, 2017
QBJIntegrated Continuous Glucose Monitoring System, Factory CalibratedClass IIClinical chemistryContract manufacturingJul 2, 2025
QDAElectrocardiograph Software For Over-The-Counter UseClass IICardiovascularContract manufacturingJun 16, 2025
QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery SystemsClass IIClinical chemistryContract manufacturingJul 2, 2025
SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-CounterClass IIClinical chemistryContract manufacturingJun 19, 2024
SBAIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone AcetateClass IIClinical chemistryContract manufacturingSep 20, 2024