HomeChina宁波海泰科迈医疗器械有限公司

宁波海泰科迈医疗器械有限公司

China
✓ Record-verifiedregistrations found in 1 markets

This company holds 15 NMPA certificates in China.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
15China registrations
Class II 12Class III 3
as of 2026-09-04
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
pendingnot queried
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
pendingnot queried
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
pendingnot queried
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
pendingnot queried
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
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.

China15 certificates (Class III 3 / II 12 / I 0), as of 2026-09-04

Company information

Country
China

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.

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20263021667一次性使用腔镜直线型切割吻合器和组件Class III
CN国械注准20243012638一次性使用电动直线型切割吻合器和钉仓Class III
CN国械注准20223010069超声软组织切割止血设备Class III
CN浙械注准20252021265一次性使用腔内闭式镜头清洗穿刺器套装Class II

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