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e-life International Co., Ltd.

Taiwan · New Taipei City · www.e-lifebracing.com

✓ Record-verifiedregistrations found in 6 markets

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

0UDI-DI device records

USUnited StatesFDA openFDA

26listed device types

Class I 26Class II 0Class III 0

plus 26 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

29registered device records

Class I 29

BRBrazilANVISA

4registered devices

Class I 4

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

SASaudi ArabiaSFDA

47registered 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

12active ARTG entries

Class I 12

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union30,438 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States26 registration records, 0 510(k), 0 PMA, 246 excluded

United Kingdom29 confirmed, 129 excluded

Brazil4 confirmed, 61 excluded

Saudi Arabia47 confirmed, 17 excluded

Canada0 confirmed, 38 excluded

Manufacturer names merged into this page: E-LIFE INTERNATIONAL CO., LTD · E-LIFE INTERNATIONAL CO., LTD. · E-Life International Co., Ltd.

Regulatory identity

UK responsible person: MDSS-UK RP LIMITED

FDA listed device types

showing 8 of 26

Cushion, Flotation 1Sling, Arm, Overhead Supported 1Orthosis, Lumbar 1Splint, Hand, And Components 1Cane, Safety Walk 1Orthosis, Limb Brace 1Orthosis, Truncal/Orthosis, Limb 1Orthosis, Corrective Shoe 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	47217	Abdominal Binder	Class I
UK	47218	Hernia Belt	Class I
UK	36206	Achilles Heel Pad	Class I
BR	81218560011	Órteses para Membros Superiores	Class I
BR	81218560016	Órteses para Membros Inferiores	Class I
BR	81218560013	Órteses para Coluna	Class I
SA	ME0000010471SFDAA00005	Cast Boot	—
SA	ME0000010471SFDAA00017	Lumbar Sacro Support	—

e-life International Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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