Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›Taiwan›Irufa Industrial Group CO.,LTD.

Irufa Industrial Group CO.,LTD.

Taiwan · Tainan · www.irufa.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN TW-MF-000046083

This company has registrations in European Union, United States, Russia — 3 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
288UDI-DI device records
Class I 288
USUnited StatesFDA openFDA
5listed device types
Class I 5Class II 0Class III 0
plus 5 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
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
2active registrations
Class 1 2
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 Union288 raw hits, 0 excluded, 288 confirmed
United States5 registration records, 0 510(k), 0 PMA
Manufacturer names merged into this page: IRUFA INDUSTRIAL GROUP CO., LTD.

Regulatory identity

EU manufacturer SRN
TW-MF-000046083
EU authorised representative
KHANG BAO INTERNATIONAL KFT

Company information

Country
Taiwan
City
Tainan
Website
www.irufa.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationPhysiotherapy equipment

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 listed device types

Joint, Shoulder, External Limb Component 1Orthosis, Limb Brace 1Joint, Knee, External Brace 1Band Or Belt, Pelvic Support 1Joint, Ankle, External Brace 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04719961661521Maternity Belt/Pregnancy Support BeltClass I
EU04719961661514Maternity Belt/Pregnancy Support BeltClass I
EU04719961661507Maternity Belt/Pregnancy Support BeltClass I
EU04719961661491Maternity Belt/Pregnancy Support BeltClass I

Similar companies

Abletech Orthopedics Corporation
Taiwan · markets 3
CONWELL MEDICAL Co., Ltd.
Taiwan · markets 4
Dyaco International Inc.
Taiwan · markets 5
Huntex Corporation
Taiwan · markets 3
I-Ming Sanitary Materials Co., Ltd.
Taiwan · markets 7
Jonson Bros. Enterprise Co., Ltd
Taiwan · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →