Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008808130

FEI Number

3008808130

Entity Name

UNITED HAYEK INDUSTRIES MANUFACTURING LTD

City/State/Country

London Barnet, GB

Establishment Address

10 Downage, London Barnet NW4 1AA, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

United Hayek Industries Manufacturing Ltd (Owner Number: 10034905)

Owner / Operator Contact Address

10 Downage, London, GB-BNE NW4 1AA, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082657

PMA Number

N/A

All Registered Proprietary Names

Hayek RTX Respirator Hayek Oscillator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYT	Ventilator, External Body, Negative Pressure, Adult (Cuirass)	Anesthesiology	Class 2	868.5935	2011-01-14

Official Correspondent

Shahar Hayek

US Agent Details

Joe Polito Business: Buffalo Respiratory Therapy, LLC Email: joe.polito@Buffalort.Com Phone: (716) 9327581

Related Public Records

Same Entity

United Hayek Industries Manufacturing Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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2518422	RESPIRONICS INC.	MURRYSVILLE, PA, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008808130. Last updated year: 2026. Please use registration number 3008808130 when referencing this establishment in official correspondence.