HomeUnited Kingdom of Great Britain and Northern IrelandQuanta Dialysis Technologies, Ltd.

Quanta Dialysis Technologies, Ltd.

United Kingdom of Great Britain and Northern Ireland · St Asaph Denbighshire
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 3 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States3 registration records, 4 510(k), 0 PMA, 4 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: Quanta Dialysis Technologies Ltd · QUANTA DIALYSIS TECHNOLOGIES LTD

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
St Asaph Denbighshire

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
QUANTA DIALYSIS TECHNOLOGIES LIMITED
Company number
06641134
Registration status
Active
Legal form
Private Limited Company
Incorporated
2008-07-08
Principal activity
32500 - Manufacture of medical and dental instruments and supplies
Registered address
THE WOODS, WARWICK, CV34 5AH

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12020 · K193670
12021 · K210661
12022 · K222067
12024 · K242269

FDA listed device types

Dialyzer, High Permeability With Or Without Sealed Dialysate System 1Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 1System, Hemodialysis, Remote Accessories 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242269SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)2024-11-01
USK222067SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set2022-11-10
USK210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset2021-08-12

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