Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020689844

FEI Number

3020689844

Entity Name

Quanta Dialysis Technologies Ltd

City/State/Country

St Asaph Denbighshire, GB

Establishment Address

Fford Richard Davies, St Asaph Denbighshire LL17 0LJ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Quanta Dialysis Technologies Ltd (Owner Number: 10080477)

Owner / Operator Contact Address

The Woods, Haywood Road, Warwick, GB-WAR CV34 5AH, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222067

PMA Number

N/A

All Registered Proprietary Names

Bicarbonate Spare Connectors Set Quanta Dialysis System Dialysate Cartridge Blood Tube Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2023-06-16
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2023-06-16

Official Correspondent

Chris Rule

US Agent Details

Suresh Persaud Business: Quanta Dialysis Technologies Inc Email: suresh.persaud@quantadt.com Phone: (978) 3940763

Related Public Records

Same Entity

Quanta Dialysis Technologies Ltd

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013536188	QUANTA DIALYSIS TECHNOLOGIES LTD	Warwick Warwickshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag
Z-0031-2024	Fresenius Medical Care Holdings, Inc.	2	2008T GEN 2 Bibag without CDX

Similar Registrations

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3015349756	DIALITY, INC.	Irvine, CA, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
3012149633	LIDER	MONTREVEL EN BRESSE Auvergne-Rhone-Alpes, FR
3005695808	SARMED SRL	IGLESIAS Sardegna, IT
3007137787	Nuwellis, Inc.	Eden Prairie, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020689844. Last updated year: 2026. Please use registration number 3020689844 when referencing this establishment in official correspondence.