HomeChinaCHANGCHUN AIK MEDICAL DEVICES CO., LTD.

CHANGCHUN AIK MEDICAL DEVICES CO., LTD.

China · Changchun
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia — 7 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class II 7
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
1 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
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 States1 registration records, 1 510(k), 0 PMA, 1 excluded
Brazil7 confirmed, 0 excluded
Manufacturer names merged into this page: CHANGCHUN AIK MEDICAL DEVICES CO., LTD. · CHANGCHUN AIK MEDICAL DEVICES CO., LTD

Company information

Country
China
City
Changchun

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

12017 · K162566

FDA listed device types

Needle, Acupuncture, Single Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK162566AIK Sterile Acupuncture Needles for Single Use2017-05-11
BR10098719028Agulhas para Acupuntura UniqmedClass II
BR81573110001Agulha para AcupunturaClass II
BR81616210001BK DISPOSABLE ACUPUNCTURE NEEDLESClass II

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