HomeJapanATOM MEDICAL CORPORATION

ATOM MEDICAL CORPORATION

Japan · Saitama-Shi
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 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
17listed device types
Class I 10Class II 7Class III 0
plus 26 registration records and 15 510(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
6 including historic records
TWTaiwanTFDA
5valid device licences
Class II 5
SGSingaporeHSA SMDR
5device registrations
CLASS C 5
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
7active ARTG entries
Class I 2IIa 1IIb 4
HKHong KongMDACS
7valid listings
Class II 2Class III 5
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
5active registrations
Class 2b 5
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 States26 registration records, 15 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: ATOM MEDICAL CORPORATION

Company information

Country
Japan
City
Saitama-Shi

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

12000
12002
32006
22010
52011
22012
12013

FDA listed device types

showing 8 of 17
Mixer, Breathing Gases, Anesthesia Inhalation 1Incubator, Neonatal Transport 1Incubator, Neonatal 1Bassinet, Hospital 1Ventilator, Emergency, Powered (Resuscitator) 1Warmer, Infant Radiant 1Unit, Neonatal Phototherapy 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK123937ATOM TRANSCAPSULE V-7072013-05-23
USK120937SUNFLOWER WARNER2012-07-06
USK111547BILI-THERAPY PAD TYPE2012-04-12

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