HomeChinaXIAMEN J-BRACE MEDICAL EQUIPMENT CO., LTD.

XIAMEN J-BRACE MEDICAL EQUIPMENT CO., LTD.

China · Xiamen Fujian
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Taiwan, Australia — 4 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
24listed device types
Class I 23Class II 1Class III 0
plus 24 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
7registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
9active ARTG entries
Class I 9
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 States24 registration records, 0 510(k), 0 PMA, 11 excluded
Brazil0 confirmed, 4 excluded
Saudi Arabia7 confirmed, 0 excluded
Manufacturer names merged into this page: XIAMEN J-BRACE MEDICAL EQUIPMENT CO., LTD. · Xiamen J Brace Medical Equipment Co Ltd

Company information

Country
China
City
Xiamen Fujian

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 listed device types

showing 8 of 24
Orthosis, Lumbar 1Binder, Elastic 1Splint, Hand, And Components 1Orthosis, Foot Drop 1Device, Transfer, Patient, Manual 1Crutch 1Support, Hernia 1Orthosis, Limb Brace 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000009087SFDAA00007AFO Ankle foot orthosis
SAME0000009087SFDAA00001shoulder immobilizer with waist strap

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