Home›Taiwan›Abletech Orthopedics Corporation

Abletech Orthopedics Corporation

Taiwan · New Taipei City · www.wellcare-supports.com

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 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

0UDI-DI device records

USUnited StatesFDA openFDA

21listed device types

Class I 21Class II 0Class III 0

plus 21 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class I 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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.

European Union523 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States21 registration records, 0 510(k), 0 PMA

United Kingdom0 confirmed, 5 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: ABLETECH ORTHOPEDICS CORPORATION · Abletech Orthopedics Corporation

FDA listed device types

showing 8 of 21

Cushion, Flotation 1Sling, Arm, Overhead Supported 1Splint, Hand, And Components 1Orthosis, Limb Brace 1Orthosis, Truncal/Orthosis, Limb 1Joint, Hip, External Brace 1Orthosis, Corrective Shoe 1Joint, Knee, External Brace 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	82411060015	Órteses de coluna	Class I
SA	ME0000010923SFDAA00001	Wellcare .( Lower (Knee/Foot/Ankle/ Cushions/ Toe Separator) Orthoses)	—
SA	ME0000010923SFDAA00003	Wellcare . Orthoses (Back\Binders\Abdominal)	—

Abletech Orthopedics Corporation

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies