HomeChinaWickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.

WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.

China · Huizhou Guangdong
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Australia — 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
3listed device types
Class I 0Class II 3Class III 0
plus 16 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
7 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIb 2Class Is (sterile) 1
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 States16 registration records, 6 510(k), 0 PMA, 3 excluded
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. · WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. · WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO., LTD.

Company information

Country
China
City
Huizhou 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 510(k) clearances by year

42017 · K172578
12023 · K222828
12024 · K241022

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Apparatus, Exhaust, Surgical 1Clamp, Vascular 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241022Sterile single use tip cleaner (WK800-S10 , WK800-S20)2024-07-11
USK222828Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A2023-03-20
USK172578Equipment Pouch2017-12-07
BR80722809008Agulha de Veres BluePadClass II

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