HomeChinaBANDEX INDUSTRIAL CORPORATION

BANDEX INDUSTRIAL CORPORATION

China · Zhuhai City Guangdong
✓ 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
14listed device types
Class I 13Class II 0Class III 0unclassified 1
plus 13 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
11registered devices
Class I 6Class II 5
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered 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 States13 registration records, 0 510(k), 0 PMA
Brazil11 confirmed, 0 excluded
Saudi Arabia3 confirmed, 0 excluded
Manufacturer names merged into this page: BANDEX INDUSTRIAL CORP. · BANDEX INDUSTRIAL CORPORATION

Company information

Country
China
City
Zhuhai City Guangdong

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 14
Pad, Eye 1Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile 1Knife, Orthopedic 1Tape And Bandage, Adhesive 1Pick, Massaging 1Applicator, Absorbent Tipped, Non-Sterile 1Toothbrush, Manual 1Polymer Patient Examination Glove 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80633180050Curativos Pós Coleta - Global XClass I
BR80633180051Curativos Pós Coleta Estéreis - Global XClass I
BR80633180052Curativos Estéreis - Global XClass I
SAME0000020391SFDAA00001SafaMed
SAME0000020391SFDAA00002SafaMed

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