HomeUnited Kingdom of Great Britain and Northern IrelandProsys International, Ltd.

Prosys International, Ltd.

United Kingdom of Great Britain and Northern Ireland · Wimbleton
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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 2Class II 1Class III 0
plus 3 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 2IIa 1
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, 1 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: PROSYS INTERNATIONAL LTD · PROSYS INTERNATIONAL LTD.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Wimbleton

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
PROSYS INTERNATIONAL LIMITED
Company number
04201958
Registration status
Active
Legal form
Private Limited Company
Incorporated
2001-04-19
Principal activity
72200 - Research and experimental development on social sciences and humanities
Registered address
SUITE 4, WIMBLEDON VILLAGE, SW19 5AP

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 · K193325

FDA listed device types

Cushion, Flotation 1Protector, Skin Pressure 1Tubes, Gastrointestinal (And Accessories) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK193325Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches2020-03-13
BR10342600046SISTEMA PARA CONTROLE DA INCONTINÊNCIA FECAL SECCOClass II

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