HomeChinaMAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.

MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.

China · Maanshan
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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 5 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
6 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 States5 registration records, 2 510(k), 0 PMA
Brazil3 confirmed, 1 excluded
Manufacturer names merged into this page: MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. · MAANSHAN BOND MEDICAL INSTRUMENTS CO., Ltd · MAANSHAN BOND MEDICAL INSTRUMENTS CO. LTD.
Same-named companies — This database also contains companies with near-identical names: Maanshan Medical Instruments Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Maanshan

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

12005 · K052846
12015 · K150903

FDA listed device types

Needle, Acupuncture, Single Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK150903EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural2015-07-15
USK052846TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE2005-12-22
BR10314290036AGULHA PARA ACUNPUTURA EACUClass II
BR80517530008AGULHAS PARA ACUPUNTURA DUXClass II
BR80517530001AGULHAS PARA ACUPUNTURA DUXClass II

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