HomeTaiwanCarilex Medical, Inc.

Carilex Medical, Inc.

Taiwan · Taoyuan City
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Australia, Israel, Russia — 7 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
10listed device types
Class I 3Class II 7Class III 0
plus 14 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 2Class II 1
4 including historic records
SASaudi ArabiaSFDA
19registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
12 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
13active ARTG entries
Class I 7IIa 4IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States14 registration records, 4 510(k), 0 PMA
Brazil3 confirmed, 0 excluded
Saudi Arabia19 confirmed, 0 excluded
Manufacturer names merged into this page: Carilex Medical, Inc. · CARILEX MEDICAL, INC. · Carilex Medical Inc · Carilex Medical , Inc

Company information

Country
Taiwan
City
Taoyuan City

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

12016 · K161410
22018 · K173407
12024 · K231646

FDA listed device types

showing 8 of 10
Lift, Patient, Ac-Powered 1Negative Pressure Wound Therapy Powered Suction Pump 1Bottle, Collection, Vacuum 1Device, Patient Transfer, Powered 1Mattress, Air Flotation, Alternating Pressure 1Bed, Flotation Therapy, Powered 1Bed, Therapeutic, Ac-Powered, Adjustable Home-Use 1Device, Transfer, Patient, Manual 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231646Carilex VT¿200-i NX2024-04-17
USK173407VT - 100, VT - 2002018-08-09
USK172725VT Dressing Kits2018-06-08
BR80311980003Kit Port Set - AvulsoClass I
BR80311980004Kit Port Set InstilaçãoClass I
BR80311980001Carilex® - Terapia de Feridas por Pressão NegativaClass II
SAME0000005850SFDAA00003DUALPLUS
SAME0000005850SFDAA00004MEDEX

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