HomeUSAINSPIRE MEDICAL SYSTEMS INC

INSPIRE MEDICAL SYSTEMS INC

USA · Golden Valley
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Singapore, Australia, Hong Kong — 4 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
2listed device types
Class I 1Class II 0Class III 1
plus 3 registration records and 0 510(k), 132 PMA
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class III 5
HKHong KongMDACS
1valid listings
Class IV 1
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 States3 registration records, 0 510(k), 132 PMA, 1 excluded
Brazil0 confirmed, 1 excluded
Manufacturer names merged into this page: INSPIRE MEDICAL SYSTEMS INC · Inspire Medical Systems Inc

Company information

Country
USA
City
Golden Valley

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
Inspire Medical Systems, Inc.
CIK
0001609550
Registration status
Active
Listing status
Listed (INSP)

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

FDA listed device types

Instrument, Surgical, Non-Powered 1Stimulator, Hypoglossal Nerve, Implanted, Apnea 1

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