HomeUSAINOGEN, INC.

INOGEN, INC.

USA · Goleta
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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
4listed device types
Class I 0Class II 4Class III 0
plus 14 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
2active device licences
Class II 2
9 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
4active ARTG entries
IIa 3IIb 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
3registrations
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 States14 registration records, 5 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: INOGEN, INC. · Inogen, Inc

Company information

Country
USA
City
Goleta

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.

Business registration

Legal name
Inogen Inc
CIK
0001294133
Registration status
Active
Listing status
Listed (INGN)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12004 · K032818
12014 · K132489
12022 · K222086
12023 · K230052
12024 · K241091

FDA listed device types

Mechanical Ventilator 1Generator, Oxygen, Portable 1Ventilator, Non-Continuous (Respirator) 1Intra-Pulmonary Percussive Vibration (Ipv) Devices 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241091SIMEOX 200 Airway Clearance Device2024-12-23
USK230052Inogen Rove 62023-06-30
USK222086Inogen Rove 4 Portable Oxygen Concentrator2022-12-09
BR80117589130Concentrador de Oxigênio PortátilClass II
CA70319INOGEN ONE OXYGEN CONCENTRATOR SYSTEMClass II
CA82666INOGEN ONE G2 OXYGEN CONCENTRATOR SYSTEMClass II

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