HomeUnited Kingdom of Great Britain and Northern IrelandMycardium AI Limited

Mycardium AI Limited

United Kingdom of Great Britain and Northern Ireland · Liverpool Liverpool
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Australia, Israel — 3 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 2 510(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
2active ARTG entries
IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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, 2 510(k), 0 PMA
Manufacturer names merged into this page: MYCARDIUM AI LTD

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Liverpool Liverpool

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
14036648
Registration status
Active
Legal form
Private Limited Company
Incorporated
2022-04-08
Principal activity
82990 - Other business support service activities n.e.c.
Registered address
THE SPINE BUILDING, LIVERPOOL, L7 3FA

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

12024 · K242062
12025 · K250670

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Digital Image Communications, Radiological 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250670EchoConfidence (USA)2025-06-30
USK2420621CMR Pro2024-11-15

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