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Home›China›ZHEJIANG B.M. INDUSTRIAL CO., LTD.

ZHEJIANG B.M. INDUSTRIAL CO., LTD.

China · Huzhou Zhejiang
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
42listed device types
Class I 38Class II 4Class III 0
plus 42 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class I 1Class II 6
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
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 States42 registration records, 2 510(k), 0 PMA, 220 excluded
Brazil7 confirmed, 109 excluded
Saudi Arabia0 confirmed, 41 excluded
Canada0 confirmed, 9 excluded
Manufacturer names merged into this page: ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD. · ZHEJIANG B.M. INDUSTRIAL CO., LTD. · ZHEJIANG DINGDA INDUSTRIAL CO.,LTD · MODUN (ZHEJIANG) INDUSTRIAL CO., LTD · ZHEJIANG ZHUOYI INDUSTRIAL & TRADING CO., LTD · ZHEJIANG B.I. INDUSTRIAL CO.,LTD
Same-named companies — This database also contains companies with near-identical names: ZHEJIANG B.I. INDUSTRIAL CO.,LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Huzhou Zhejiang

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

12005 · K033405
12023 · K220657

FDA listed device types

showing 8 of 42
Cushion, Flotation 1Device, Occlusion, Umbilical 1Bag, Urine Collecting, Ureterostomy 1Pad, Menstrual, Unscented 1Splint, Hand, And Components 1Adaptor, Ureteral Catheter 1Dressing, Wound, Occlusive 1Depressor, Tongue, Non-Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220657Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)2023-02-10
USK033405LONGFEI LFY-I-5 OXYGEN CONCENTRATOR2005-10-18
BR80808480053Luva cirúrgica de látex natural, texturizada, anatômica, estéril, com Class II
BR80808480054Luva cirúrgica de látex natural, texturizada, anatômica, estéril, sem Class II
BR81365569008LUVA CIRÚRGICA DE LÁTEX COM PÓ - PHARMAPLUSClass II

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