QI Diagnostics Limited

Registered establishment in Mongkok, Hong Kong, China. 1 device type.

Registry build 21.09.26

QI Diagnostics Limited is a specification developer holding a current FDA establishment registration. The registration covers System, Breath Measurement. Its earliest product listing with the FDA dates from 2022.

Registration

FDA registration record for QI Diagnostics Limited
Registered name QI DIAGNOSTICS LIMITED
Status Registered
Registration expires 2026
Registration number 3026284320
FEI number 3026284320
Establishment type Specification developer, Manufacturer, Exporter

Chinese Registration

Chinese company register details for QI Diagnostics Limited
Chinese legal name 氣葩科技有限公司
Source Hong Kong company register lookup

Location

Address of QI Diagnostics Limited
City Mongkok
Province Hong Kong
Address 10/F, Fuk Chiu Factory Building
Postal code –
Country China

What It Makes

Device types QI Diagnostics Limited is registered to make
Device type Class Listed under the names Listed since Chinese makers
System, Breath Measurement Class 1 Ketoair 2022 3

From the Company

Published by the company on its own website, not by the FDA.

Information published by QI Diagnostics Limited
Main products KetoAir Ketone Breathalyzer, Lung Cancer Breathalyzer, Metabolic Health Breathalyzer
Certifications FDA Class 1, ISO 13485:2012
OEM and ODM Offered

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

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2,581device types they are registered for
340,248device records, each naming its maker
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