HomeTaiwanWandy Rubber Industrial Co., Ltd.

Wandy Rubber Industrial Co., Ltd.

Taiwan · Taipei
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
4listed device types
Class I 0Class II 4Class III 0
plus 10 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
3 including historic records
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 States10 registration records, 4 510(k), 0 PMA
Manufacturer names merged into this page: WANDY RUBBER INDUSTRIAL CO., LTD

Company information

Country
Taiwan
City
Taipei

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

22001 · K002227
12003 · K031174
12013 · K132998

FDA listed device types

Electrode, Cutaneous 1Device, Iontophoresis, Other Uses 1Electrosurgical Patient Return Electrode 1Electrode, Electrocardiograph 1

Registration details (sample)

MarketIdentifierNameClass / date
USK132998WANDY SELF-ADHESIVE ELECTRODES2013-12-20
USK031174BODY SIGNAL ECG ELECTRODE2003-07-10
USK002227WANDY SILICONE CONDUCTIVE RUBBER PAD2001-02-02

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