Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015766032

FEI Number

3015766032

Entity Name

OPUM TECHNOLOGIES SERVICES

City/State/Country

Newmarket Auckland, NZ

Establishment Address

University of Auckland Newmarket Campus, Building 903, 314-390 Khyber Pass Road, Newmarket, Auckland, 1023 , N, Khyber Pass Road,, Newmarket Auckland 1023, NZ

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

OPUM TECHNOLOGIES SERVICES LIMITED (Owner Number: 10089032)

Owner / Operator Contact Address

University of Auckland Newmarket Campus, Building 903, 314-390 Khyber Pass Road, Newmarket, Auckland, NZ-AUK 1023, NZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Digital Knee DK-013 Digital Knee DK-011 Digital Knee DK-015 Digital Knee DK-014 Digital Knee DK-010 Digital Knee DK-008 Digital Knee DK-016 Digital Knee DK-009 Digital Knee DK-012 myDigitalKnee App Digital Knee Sensor DK-017

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQX	Goniometer, Ac-Powered	Orthopedic	Class 1	888.1500	2023-10-30

Official Correspondent

Alexandra Wilson

US Agent Details

David Smith Business: OPUM US INC Email: david.smith@opumtechnologies.com Phone: (925) 9893885

Related Public Records

Same Entity

OPUM TECHNOLOGIES SERVICES LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015766032. Last updated year: 2026. Please use registration number 3015766032 when referencing this establishment in official correspondence.