LABWORKS AUSTRALIA PTY LTD

FDA Device Registration & Listing · Ferntree Gully Victoria, AU · Registration 3003919052

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
3003919052
FEI Number
3003919052
Entity Name
LABWORKS AUSTRALIA PTY LTD
City/State/Country
Ferntree Gully Victoria, AU
Establishment Address
Unit 26 756 Burwood Highway, Ferntree Gully Victoria 3152, AU
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Labworks Australia Pty Ltd (Owner Number: 10037346)
Owner / Operator Contact Address
Unit 26 756 Burwood Highway, Ferntree Gully, AU-VIC 3152, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Biopsy Pad Activated Carbon Filter Cassette Sponge

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KET Filters, Cell Collection, Tissue Processing Pathology Class 1 864.3010 2011-07-07

Official Correspondent

Alan Davis

US Agent Details

Jerry Doane Business: FDA Basics LLC Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Labworks Australia Pty Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3013548489 ADVANCE SENTRY CORPORATION Markham Ontario, CA
3011781201 GUANGZHOU KOMASPEC MECHANICAL AND ELECTRICAL PRODUCTS MANUFA Huashan Town, Huadu District, Guangdong, CN
3010692993 DIAPATH S.P.A. Martinengo Bergamo, IT
1220477 ISOMEDIX OPERATIONS INC. Northborough, MA, US
2029275 Sterigenics U.S., LLC Corona, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003919052. Last updated year: 2026. Please use registration number 3003919052 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.