Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007697908

FEI Number

3007697908

Entity Name

Novapharm Research Australia Pty Ltd

City/State/Country

Rosebery New South Wales, AU

Establishment Address

3 - 11 Primrose Ave, Rosebery New South Wales 2018, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Novapharm Research Australia Pty Ltd (Owner Number: 10029371)

Owner / Operator Contact Address

3 - 11 Primrose Ave, Rosebery, AU-NSW 2018, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Getinge Clean MIS Detergent Asepti Autozyme Pr Asepti Multizyme Epizyme Ultra Epizyme Manual Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2009-05-07

Official Correspondent

Tjun Heng

US Agent Details

Bob MacDonald Business: Scientific and Regulatory Consultants, Inc Email: bmacdonald@srcconsultants.com Phone: (260) 2446270

Related Public Records

Same Entity

Novapharm Research Australia Pty Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3018811167	MEDIVATORS INC	Rogers, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007697908. Last updated year: 2026. Please use registration number 3007697908 when referencing this establishment in official correspondence.