HomeChinaBytech(Dongtai) Co., Ltd.

Bytech(Dongtai) Co., Ltd.

China · Dongtai
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan — 4 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
2510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class I 10
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class I 2
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, 2 510(k), 0 PMA
Brazil10 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: Bytech (Dongtai) Co., Ltd · bytech (dongtai) co.,Ltd.

Company information

Country
China
City
Dongtai

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 510(k) clearances by year

12013 · K130101
12021 · K212899

Registration details (sample)

MarketIdentifierNameClass / date
USK212899Disposable Vinyl/Nitrile Blend Medical Examination Gloves2021-12-11
USK130101BYTECH2013-11-08
BR80630310003Luva para Procedimento de Vinil Não EstérilClass I
BR80495510062MEDIX BRASIL LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO DE VINIL COM PÓClass I
BR81818100008luva de vinil sem pó vabeneClass I
SAME0000008992SFDAA00001Unique
SAME0000013124SFDAA00001Vinyl Disposable Clear Hand Gloves Powder Free

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