HomeTaiwanPOWER WELL HEALTHCARE TECHNOLOGY CO., LTD.

POWER WELL HEALTHCARE TECHNOLOGY CO., LTD.

Taiwan · Changhua County
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, Australia, Israel — 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
22listed device types
Class I 18Class II 3Class III 0unclassified 1
plus 21 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
18registered 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
1active ARTG entries
Class I 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States21 registration records, 0 510(k), 0 PMA, 37 excluded
Brazil0 confirmed, 7 excluded
Saudi Arabia18 confirmed, 2 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: POWER WELL HEALTHCARE TECHNOLOGY CO., LTD. · Power Well Healthcare Technology Co Ltd · POWER WELL HEALTHCARETECHNOLOGY CO., LTD.

Company information

Country
Taiwan
City
Changhua County

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 22
Joint, Knee, External Brace 1Orthosis, Lumbar 1Splint, Temporary Training 1Binder, Abdominal 1Splint, Clavicle 1Sling, Arm 1Binder, Elastic 1Support, Hernia 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000009196SFDAA00007Medical Compression Stocking
SAME0000009196SFDAA00009Elastic Wrist Brace left Right

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