Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021247813

FEI Number

3021247813

Entity Name

AusMed Global Limited

City/State/Country

Hong Kong, HK

Establishment Address

Unit 232, 2/F, Building 19W, 19 Science Park West Avenue, Hong Kong Science Park, Pak Shek Kok, New Territories, Hong Kong 00000, HK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AusMed Global Limited (Owner Number: 10083241)

Owner / Operator Contact Address

RM 1701, 17/F Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong, HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KetoMetrics Breath Ketone Testing Kits KetoMetrics Breath Ketone Analyser

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2021-12-29

Official Correspondent

Christine Yip

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

AusMed Global Limited

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 3021247813. Last updated year: 2026. Please use registration number 3021247813 when referencing this establishment in official correspondence.