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TG Eakin Limited

✓ 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 2Class II 0Class III 0
plus 2 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 States2 registration records, 0 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 1 excluded
Saudi Arabia17 confirmed, 0 excluded
Manufacturer names merged into this page: T.G. EAKIN, LTD. · TG EAKIN LIMITED (PART OF EAKIN HEALTHCARE) · TG Eakin Limited · TG EAKIN LTD.
Same-named companies — This database also contains companies with near-identical names: T.G. EAKIN, LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

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

Protector, Ostomy 1Bag, Drainage, With Adhesive, Ostomy 1

Registration details (sample)

MarketIdentifierNameClass / date
BR82105440001Bolsas para ostomia DOT sistema 2 PEÇASClass I
BR82105449001Placas para ostomia DOT sistema 2 PEÇASClass II
BR82105440002Sistema Eakin® DOT - 1 peçaClass I
SAME0000013187SFDAA00001Eakin Stoma support belt—
SAME0000013187SFDAA00002Pelican Convex Drainable—

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