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TG EAKIN LIMITED (PART OF EAKIN HEALTHCARE)

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in Brazil, Saudi Arabia — 2 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

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

SASaudi ArabiaSFDA

17registered 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

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.

United States0 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil3 confirmed, 1 excluded

Saudi Arabia17 confirmed, 0 excluded

Manufacturer names merged into this page: TG EAKIN LIMITED (PART OF EAKIN HEALTHCARE) · TG Eakin Limited · TG EAKIN LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
BR	82105440001	Bolsas para ostomia DOT sistema 2 PEÇAS	Class I
BR	82105449001	Placas para ostomia DOT sistema 2 PEÇAS	Class II
BR	82105440002	Sistema Eakin® DOT - 1 peça	Class I
SA	ME0000013187SFDAA00001	Eakin Stoma support belt	—
SA	ME0000013187SFDAA00002	Pelican Convex Drainable	—

TG EAKIN LIMITED (PART OF EAKIN HEALTHCARE)

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

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