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Infervision Medical Technology Co., Ltd.

China · Beijing

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Singapore, Australia — 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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 6 registration records and 5 510(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

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 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 States6 registration records, 5 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: Beijing Infervision Healthcare Medical Technology Co., Ltd.

Same-named companies — This database also contains companies with near-identical names: Beijing Infervision Healthcare Medical Technology Co., Ltd., Beijing Infervision Technology Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12021 · K211179

22025 · K250237

22026 · K260973

FDA listed device types

System, Image Processing, Radiological 1Radiological Computer-Assisted Triage And Notification Software 1Automated Radiological Image Processing Software 1Lung Computed Tomography System, Computer-Aided Detection 1

Market	Identifier	Name	Class / date
US	K260973	InferOperate Suite	2026-07-07
US	K252261	InferCare RECIST	2026-03-13
US	K250237	InferOperate Suite	2025-09-15

Infervision Medical Technology Co., Ltd.

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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