Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002808271

FEI Number

3002808271

Entity Name

Steritech

City/State/Country

Dandenong Victoria, AU

Establishment Address

160 South Gippsland Highway, Dandenong Victoria 3175, AU

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Steritech (Owner Number: 10077638)

Owner / Operator Contact Address

5-7 Widemere Road, Wetherill Park, AU-NSW 2164, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NovoSorb ® BTM Remplir, MODEL ON-152, ON-203, ON-304, ON-405 RB12 Suction Rectal Biopsy System NovoSorb ® MTX Striate+, MODEL OCG-152, OCG-203, OCG-304, OCG-405 perFORM, MODEL perf1520, perf2030, perf3040

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QSZ	Absorbable Synthetic Wound Dressing	Unknown	Class U	N/A	2024-05-15
JXI	Cuff, Nerve	Neurology	Class 2	882.5275	2025-04-04
FCK	Instrument, Biopsy, Suction	Gastroenterology, Urology	Class 2	876.1075	2020-09-11
QSZ	Absorbable Synthetic Wound Dressing	Unknown	Class U	N/A	2024-05-15
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2022-08-16

Official Correspondent

Joseph Azary

US Agent Details

Joseph Azary Business: Aztech Regulatory and Quality LLC Email: aztechregulatory@gmail.com Phone: (203) 2426670

Related Public Records

Same Entity

Steritech

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 3002808271. Last updated year: 2026. Please use registration number 3002808271 when referencing this establishment in official correspondence.