HomeChinaManteia Technologies Co., Ltd.

Manteia Technologies Co., Ltd.

China · Xiamen City
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Australia, Hong Kong — 5 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
3listed device types
Class I 0Class II 3Class III 0
plus 7 registration records and 6 510(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
4 including historic records
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIb 3
HKHong KongMDACS
3valid listings
Class III 3
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 States7 registration records, 6 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: MANTEIA TECHNOLOGIES CO.,LTD. · MANTEIA TECHNOLOGIES CO., LTD.

Company information

Country
China
City
Xiamen City

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.

FDA 510(k) clearances by year

32023 · K223834
22025 · K250780
12026 · K251351

FDA listed device types

Accelerator, Linear, Medical 1System, Planning, Radiation Therapy Treatment 1Radiological Image Processing Software For Radiation Therapy 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251351AccuContour 4.02026-01-23
USK250780ARTAssistant2025-12-05
USK250696AccuCheck2025-10-24

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