HomeUSANihon Kohden Orangemed, Inc.

Nihon Kohden Orangemed, Inc.

USA · Santa Ana
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, 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
3listed device types
Class I 1Class II 2Class III 0
plus 6 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
2 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
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 States6 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: NIHON KOHDEN ORANGEMED, LLC · NIHON KOHDEN ORANGEMED, INC

Company information

Country
USA
City
Santa Ana

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

12018 · K181695
12020 · K192307
12022 · K213521
12023 · K222644
12024 · K231778

FDA listed device types

Tubing, Pressure And Accessories 1Sv70 Ventilator 1Ventilator, Continuous, Facility Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK231778Nihon Kohden NKV-550 Series Ventilator System2024-03-01
USK222644Nihon Kohden NKV-440 Ventilator System2023-05-31
USK213521Nihon Kohden NKV-330 Ventilator System2022-07-01

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