HomeUSAHealth Care Mfg., Inc.

Health Care Mfg., Inc.

USA · Springfield
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 16Class II 1Class III 0
plus 17 registration records and 7 510(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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 States17 registration records, 7 510(k), 0 PMA, 344 excluded
Brazil0 confirmed, 10 excluded
Saudi Arabia0 confirmed, 15 excluded
Canada0 confirmed, 11 excluded
Manufacturer names merged into this page: APEX HEALTH CARE MFG., INC.
Same-named companies — This database also contains companies with near-identical names: APEX HEALTH CARE MFG., INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Springfield

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

51995 · K952441
22002 · K022667

FDA listed device types

showing 8 of 17
Exerciser, Non-Measuring 1Stand, Infusion 1Stool, Operating-Room 1Aid, Transfer 1Table, Examination, Medical, Powered 1Chair And Table, Medical 1Lift, Patient, Non-Ac-Powered 1Scale, Patient 1

Registration details (sample)

MarketIdentifierNameClass / date
USK022667HCMI X-RAY2002-10-22
USK022737HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC2002-10-22
USK952441LEGEND1995-06-19

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