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Home›USA›Maine Standards Company, LLC

Maine Standards Company, LLC

USA · Windham
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Singapore — 2 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
30510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 30 510(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
15device registrations
CLASS B 12CLASS C 3
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 States0 registration records, 30 510(k), 0 PMA, 7 excluded

Company information

Country
USA
City
Windham

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

72001
22002
12003
22004
12005
22006
12007
12008
32009
22011
12012
12013
12014
12015
12016
32017

Registration details (sample)

MarketIdentifierNameClass / date
USK170864VALIDATE D-Dimer Calibration Verification / Linearity Test Kit2017-06-21
USK163498VALIDATE Heparin Calibration Verification/Linearity Test Kit2017-03-16
USK162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit2017-01-05

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