QI DIAGNOSTICS LIMITED

FDA Device Registration & Listing · Mongkok Hong Kong, CN · Registration 3026284320

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
3026284320
FEI Number
3026284320
Entity Name
QI DIAGNOSTICS LIMITED
City/State/Country
Mongkok Hong Kong, CN
Establishment Address
10/F, Fuk Chiu Factory Building, 20 Bute Street HKSAR, Mongkok Hong Kong -, CN
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Qi Diagnostics Limited (Owner Number: 10086835)
Owner / Operator Contact Address
10/F, Fuk Chiu Factory Building, 20 Bute Street, HKSAR, Mongkok, CN-NOTA -, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ketoair

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NRH System, Breath Measurement Clinical Chemistry Class 1 862.1820 2022-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Qi Diagnostics Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026284320. Last updated year: 2026. Please use registration number 3026284320 when referencing this establishment in official correspondence.
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