HomeUnited Kingdom of Great Britain and Northern IrelandTristel Solutions Limited

Tristel Solutions Limited

United Kingdom of Great Britain and Northern Ireland · Snailwell
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 8 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
1listed device types
Class I 0Class II 1Class III 0
plus 2 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
7valid device licences
Class I 2Class II 5
SGSingaporeHSA SMDR
5device registrations
CLASS C 5
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
12active ARTG entries
Class I 6IIb 5Class Is (sterile) 1
HKHong KongMDACS
6valid listings
Class III 6
ILIsraelAMAR
8registrations
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 States2 registration records, 2 510(k), 0 PMA
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: TRISTEL SOLUTION LTD · TRISTEL SOLUTIONS LTD. · Tristel Solutions Ltd.
Same-named companies — This database also contains companies with near-identical names: TRISTEL SOLUTION LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Snailwell

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

Company number
03518312
Registration status
Active
Legal form
Private Limited Company
Incorporated
1998-02-27
Principal activity
20590 - Manufacture of other chemical products n.e.c.
Registered address
UNIT 1B LYNX BUSINESS PARK, NEWMARKET, CB8 7NY

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

12023 · DEN220041
12025 · K242732

FDA listed device types

Foam Or Gel Chemical Sterilant/High Level Disinfectant 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242732Tristel OPH2025-05-09
USDEN220041Tristel Duo ULT2023-06-02
SAME0000002234SFDAA00039Duo Wipes

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