HomeChinaZhejiang Kindly Medical Device Co., Ltd.

Zhejiang Kindly Medical Device Co., Ltd.

China · Wenzhou
✓ 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
16listed device types
Class I 4Class II 12Class III 0
plus 30 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
79registered devices
Class I 2Class II 77
82 including historic records
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 States30 registration records, 7 510(k), 0 PMA, 5 excluded
Brazil79 confirmed, 9 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD · ZHEIJIANG KINDLY MEDICAL DEVICES CO., LTD. · ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. · Zhejiang Kindly Medical Devices Co. Ltd (KDL)
Same-named companies — This database also contains companies with near-identical names: Zhejiang Kindly Medical Devices Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Wenzhou

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

32018 · K181069
22022 · K223334
12023 · K233037
12026 · K252899

FDA listed device types

showing 8 of 16
System, Blood Collection, Vacuum-Assisted, Manual 1Adaptor, Holder, Syringe 1Adaptor, Catheter 1Needle, Aspiration And Injection, Disposable 1Parenteral Administration Kit 1Low Dead Space Needle, Single Lumen, Hypodermic 1Ophthalmic Needle 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252899Female Culture Device; Male Culture Device; Transfer Device; Access Device2026-06-02
USK233037Sterile Hypodermic Needles for Single Use2023-12-12
USK223334Sterile Hypodermic Needles for Single Use2022-12-16
BR80288099031Cateter Intravenoso com Dispositivo de SegurançaClass II
BR80937159053SOL-M AGULHA PARA APLICAÇÃO DE INSULINA COM CANETAClass II
BR80937159054PAGUE MENOS AGULHA PARA CANETA DE INSULINAClass II

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