Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040277182

FEI Number

3040277182

Entity Name

QUADRALENE LTD

City/State/Country

DERBY, GB

Establishment Address

Unit 3, Andressey Way, DERBY DE21 6YH, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Quadralene Ltd (Owner Number: 10093794)

Owner / Operator Contact Address

Unit 3, Andressey Way, DERBY, GB-DER DE21 6YH, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Xen Xcelerate Xen Neutral+ Xen Universal+ Xen Universal Xen Sanizyme+ Xen Enzymatic+ Xen Rinse Xen Enzymatic Xen Neutral Xen Xcelerate+ Lumen Xen QuadX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-07-11
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2025-07-23

Official Correspondent

Jason Ambrose-Jones

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

Quadralene Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040277182. Last updated year: 2026. Please use registration number 3040277182 when referencing this establishment in official correspondence.