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TRULIFE LIMITED

USA · Bellingham

✓ Record-verifiedregistrations found in 6 markets

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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

21listed device types

Class I 21Class II 0Class III 0

plus 31 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

SASaudi ArabiaSFDA

21registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States31 registration records, 1 510(k), 0 PMA

Brazil2 confirmed, 1 excluded

Saudi Arabia21 confirmed, 1 excluded

Manufacturer names merged into this page: TRULIFE, INC. · TRULIFE LIMITED · TRULIFE LTD. · TRULIFE, LTD. · TRULIFE LTD · TRULIFE

FDA 510(k) clearances by year

11993 · K934970

FDA listed device types

showing 8 of 21

Orthosis, Lumbar 1Prosthesis, Breast, External, No Adhesive 1Orthosis, Limb Brace 1Orthosis, Truncal/Orthosis, Limb 1Orthosis, Abdominal 1Binder, Medical, Therapeutic 1Stocking, Elastic 1Orthosis, Thoracic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K934970	DUET	1993-12-10
BR	80037520027	POSICIONADORES PARA PROCEDIMENTOS SIMPLES E CIRÚRGICOS	Class I
BR	80102513188	Posicionadores Trulife Pressurecare	Class I
SA	ME0000000938SFDAA00019	Lerman Non-Invasive Halo	—
SA	ME0000000938SFDAA00020	GUNSLINGER II	—

TRULIFE LIMITED

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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