HomeTaiwanGIGANTEX Composite Technologies Co., Ltd

GIGANTEX Composite Technologies Co., Ltd

Taiwan · Changhua County · www.gigantex.com.tw
✓ Record-verifiedregistrations found in 2 marketsEU SRN TW-MF-000035693

This company has registrations in European Union, Australia — 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
4UDI-DI device records
Class I 4
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
Class I 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.

European Union215 raw hits, 211 excluded, 4 confirmed
United Kingdom0 confirmed, 3 excluded

Regulatory identity

EU manufacturer SRN
TW-MF-000035693
EU authorised representative
CMC Medical Devices & Drugs SL

Company information

Country
Taiwan
City
Changhua County
Website
www.gigantex.com.tw
Product categories
Integrated Care, Rehabilitation & HomecareHomecare, long-term care & ageing

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.

Registration details (sample)

MarketIdentifierNameClass / date
EU04719896060031Class I
EU04719896060000Class I
EU04719896060017Class I
EU04719896060024Class I

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