ENTERIX PTY LTD.

FDA Device Registration & Listing · NORTH RYDE New South Wales, AU · Registration 3005311019

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005311019
FEI Number
3005311019
Entity Name
ENTERIX PTY LTD.
City/State/Country
NORTH RYDE New South Wales, AU
Establishment Address
UNIT 15/2 EDEN PARK DRIVE, NORTH RYDE New South Wales 2113, AU
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Enterix Inc (Owner Number: 9042500)
Owner / Operator Contact Address
236 Fernwood Avenue, Edison, NJ 08837, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K170548
PMA Number
N/A

All Registered Proprietary Names

InSure FIT FOBT Controls InSure ONE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OSL Control, Fecal Occult Blood Hematology Class 2 864.6550 2014-09-05
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2017-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

Erica Franco Email: erica.franco@enterix.com Phone: (732) 4251598

Related Public Records

Same Entity

Enterix Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K162333 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step Fecal Occult Blood (FOB) Test 2017-05-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005311019. Last updated year: 2026. Please use registration number 3005311019 when referencing this establishment in official correspondence.
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