Ai Medical AG

Switzerland · Zollikon

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Singapore — 2 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

4listed device types

Class I 0Class II 3Class III 1

plus 11 registration records and 3 510(k), 2 PMA

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

1device registrations

CLASS B 1

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 States11 registration records, 3 510(k), 2 PMA, 81 excluded

Brazil0 confirmed, 14 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 9 excluded

Manufacturer names merged into this page: Harrison-AI Medical Pty Ltd · PERIMETER MEDICAL IMAGING AI, INC.

FDA 510(k) clearances by year

12021 · K203578

12023 · K223659

12026 · K253818

FDA listed device types

Radiological Computer-Assisted Prioritization Software For Lesions 1System, Imaging, Optical Coherence Tomography (Oct) 1Radiological Computer-Assisted Triage And Notification Software 1Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253818	Annalise Enterprise	2026-03-03
US	K223659	Jazz	2023-09-22
US	K203578	OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System	2021-02-25

Ai Medical AG

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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