Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030927592

FEI Number

3030927592

Entity Name

STRATOS MEDTECH PTY LTD

City/State/Country

Maryborough Queensland, AU

Establishment Address

319 Kent Street, Maryborough Queensland 4650, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Stratos MedTech (Owner Number: 10046257)

Owner / Operator Contact Address

319 Kent Street, Maryborough, AU-QLD 4650, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160758

PMA Number

N/A

All Registered Proprietary Names

PeriCoach

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HIR	Perineometer	Obstetrics/Gynecology	Class 2	884.1425	2018-11-28

Official Correspondent

Karien Maskelyne

US Agent Details

Andrea Mackie Business: Pearl Pathways Email: mward@pearlpathways.com Phone: (317) 8999341

Related Public Records

Same Entity

Stratos MedTech

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 3030927592. Last updated year: 2026. Please use registration number 3030927592 when referencing this establishment in official correspondence.