Hometri m medical

tri m medical

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 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
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
6listed device types
Class I 4Class II 2Class III 0
plus 6 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
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 States6 registration records, 5 510(k), 0 PMA, 28 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia1 confirmed, 1 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: TRI-TECH MEDICAL, INC. · TRI/BOR MEDICAL INC. · tri m medical

Company information

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

51991 · K904718

FDA listed device types

Bottle, Collection, Vacuum 1Regulator, Vacuum 1Apparatus, Suction, Single Patient Use, Portable, Nonpowered 1Humidifier, Non-Direct Patient Interface (Home-Use) 1Regulator, Pressure, Gas Cylinder 1Flowmeter, Tube, Thorpe, Back-Pressure Compensated 1

Registration details (sample)

MarketIdentifierNameClass / date
USK904718AERO-GEN NUBULIZER SYSTEM1991-04-01
USK904717MICRO-VENT NEBULIZER SYSTEM1991-04-01
USK904719DISPOSABLE FACE MASK1991-01-02
SAME0000001806SFDAA00013surgical pad
CA66988MICRO-VENT NEBULIZER SYSTEMClass II

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