Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044707988

FEI Number

3044707988

Entity Name

SPIRACHECK LIMITED

City/State/Country

NORTHWOOD Hillingdon, GB

Establishment Address

18 BOURNE END ROAD, MIDDLESEX, NORTHWOOD Hillingdon HA6 3BS, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spiracheck Limited (Owner Number: 10095336)

Owner / Operator Contact Address

18 BOURNE END ROAD, MIDDLESEX, NORTHWOOD, GB-HIL HA6 3BS, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SpiraCheck

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGK	Gas, Collecting Vessel	Anesthesiology	Class 1	868.1575	2026-02-27

Official Correspondent

No official correspondent registered.

US Agent Details

Binoy Joese Business: I3CGlobal US Inc Email: usagent@i3cglobal.us Phone: (304) 3001001

Related Public Records

Same Entity

Spiracheck 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 3044707988. Last updated year: 2026. Please use registration number 3044707988 when referencing this establishment in official correspondence.