HomeUSAGaymar Industries, Inc.

Gaymar Industries, Inc.

USA · Orchard Park
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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
27510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 27 510(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
10active device licences
Class II 10
14 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States0 registration records, 27 510(k), 0 PMA
Canada10 confirmed, 0 excluded
Manufacturer names merged into this page: GAYMAR INDUSTRIES INC

Company information

Country
USA
City
Orchard Park

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

51976
11977
21978
11980
11981
21983
21985
21988
21991
21992
11993
11995
11996
21997
12008
12011

Registration details (sample)

MarketIdentifierNameClass / date
USK100585MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA79002011-01-20
USK073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP2008-05-08
USK962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM1997-04-30
CA60816MUL-T-BLANKETClass II
CA69276PLEXUS OVERLAY - ALTERNATING PRESSURE THERAPY MATTRESS OVERLAYClass II
CA69334G.A.P. OVERLAY-ALTERNATING PRESSURE CHAIR PAD OVERLAYClass II

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