HomeTaiwanAcute Ideas Co. , Ltd.

Acute Ideas Co. , Ltd.

Taiwan · Taipei
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 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
13listed device types
Class I 10Class II 3Class III 0
plus 17 registration records and 2 510(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
TWTaiwanTFDA
1valid device licences
Class I 1
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 States17 registration records, 2 510(k), 0 PMA, 1 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: Acute Ideas 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

12002 · K023711
12012 · K113315

FDA listed device types

showing 8 of 13
Pump, Breast, Powered 1Continuous Measurement Thermometer 1Strip, Temperature, Forehead, Liquid Crystal 1Pump, Breast, Non-Powered 1Orthosis, Lumbar 1Dispenser, Liquid Medication 1Nursing Pad, Hydrogel 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK113315RUMBLE TUFF2012-11-20
USK023711DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE2002-11-21

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