HomeViet NamMani Hanoi Co. Ltd

Mani Hanoi Co. Ltd

Viet Nam · Thai Nguyen Province
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, South Korea — 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
19listed device types
Class I 14Class II 5Class III 0
plus 23 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered 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
3GMP quality-system certificates
Import 3
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 States23 registration records, 0 510(k), 0 PMA, 2 excluded
Manufacturer names merged into this page: Mani Hanoi Co. Ltd · Mani Hanoi Co. Ltd Pho Yen 2 Factory

Company information

Country
Viet Nam
City
Thai Nguyen Province

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

showing 8 of 19
Cannula, Trocar, Ophthalmic 1Spreader, Pulp Canal Filling Material, Endodontic 1Knife, Ophthalmic 1Bur, Dental 1Plugger, Root Canal, Endodontic 1Reamer, Pulp Canal, Endodontic 1Staple, Removable (Skin) 1File, Pulp Canal, Endodontic 1

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