HomeUSAACCUTRON, INC.

ACCUTRON, INC.

USA · Phoenix
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel — 6 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
13listed device types
Class I 10Class II 3Class III 0
plus 15 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
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
7 including historic records
TWTaiwanTFDA
2valid device licences
Class I 1Class II 1
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 1IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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 States15 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: ACCUTRON, INC. · ACCUTRON INC.

Company information

Country
USA
City
Phoenix

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

21997 · K965239
11999 · K992421
12004 · K033503
12005 · K052335

FDA listed device types

showing 8 of 13
Gas-Machine, Anesthesia 1Ventilator, Emergency, Manual (Resuscitator) 1Apparatus, Gas-Scavenging 1Mask, Oxygen, Non-Rebreathing 1Regulator, Pressure, Gas Cylinder 1Connector, Airway (Extension) 1Mask, Oxygen 1Transducer, Gas Pressure 1

Registration details (sample)

MarketIdentifierNameClass / date
USK052335ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA2005-11-23
USK033503RFS VACUUM GAUGE SCAVENGING CIRCUIT2004-03-12
USK992421GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 340761999-10-27

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