HomeUnited Kingdom of Great Britain and Northern IrelandMIRADA MEDICAL LIMITED

MIRADA MEDICAL LIMITED

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

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, 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
2listed device types
Class I 1Class II 1Class III 0
plus 5 registration records and 8 510(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
6active device licences
Class II 6
8 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States5 registration records, 8 510(k), 0 PMA, 1 excluded
Brazil1 confirmed, 0 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: MIRADA MEDICAL LIMITED · MIRADA MEDICAL LTD. · MIRADA MEDICAL LTD

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Oxford

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
06515901
Registration status
Active
Legal form
Private Limited Company
Incorporated
2008-02-27
Principal activity
46460 - Wholesale of pharmaceutical goods / 58290 - Other software publishing
Registered address
NEW BARCLAY HOUSE, OXFORD, OX2 0HP

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

22010 · K102687
12013 · K130393
12015 · K143020
22018 · K182016
12020 · K202297
12022 · K220779

FDA listed device types

System, Image Processing, Radiological 1Medical Device Data System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220779XD2022-04-15
USK202297Aline Ablation Intelligence2020-09-11
USK182016Simplicit90Y2018-12-06
BR80117581162Mirada Simplicit90Y 2.8.0Class II
CA81220FUSION SOFTWAREClass II
CA82220MIRADA XDClass II
CA84246MIRADA XDClass II

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