HomeTaiwanA-Spine Asia, Co., Ltd.

A-Spine Asia, Co., Ltd.

Taiwan · Taipei Neihu District
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 1Class II 1
3 including historic records
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
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
9active ARTG entries
Class I 2IIb 7
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 States0 registration records, 1 510(k), 0 PMA, 207 excluded
Brazil2 confirmed, 40 excluded
Saudi Arabia0 confirmed, 3 excluded
Canada0 confirmed, 14 excluded
Manufacturer names merged into this page: A-SPINE ASIA CO., LTD.

Company information

Country
Taiwan
City
Taipei Neihu District

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

12011 · K111883

Registration details (sample)

MarketIdentifierNameClass / date
USK111883SMARTLOC SPINAL FIXATION SYSTEM2011-10-18
BR10210550145INSTRUMENTAIS PARA REDMOND A-SPINE TiClass II
BR10210550146INSTRUMENTAIS PARA REDMOND A-SPINEClass I

Similar companies

Abletech Orthopedics Corporation
Taiwan · markets 3
Aero Pro Co., Ltd.
Taiwan · markets 2
AiQ Smart Clothing Inc.
Taiwan · markets 0
Anest Iwata Sparmax Co., Ltd.
Taiwan · markets 3
ANGELINE GROUP LTD
Taiwan · markets 1
Apex Biotechnology Corporation
Taiwan · markets 6
Is this your company? Claim the page, add information or report a data error.Claim / report an error →