HomeUSAFLUKE BIOMEDICAL, LLC

FLUKE BIOMEDICAL, LLC

USA · Cleveland
✓ 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
2listed device types
Class I 1Class II 1Class III 0
plus 3 registration records and 6 510(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
1active device licences
Class II 1
18 including historic records
TWTaiwanTFDA
pendingnot queried
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 States3 registration records, 6 510(k), 0 PMA, 1 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: FLUKE BIOMEDICAL · FLUKE BIOMEDICAL, LLC

Company information

Country
USA
City
Cleveland

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

22008 · K083347
22011 · K110429
12012 · K121722
12013 · K121860

FDA listed device types

Tester, Defibrillator 1Shield, Protective, Personnel 1

Registration details (sample)

MarketIdentifierNameClass / date
USK121860ESA6152013-01-25
USK121722ESA620 ELECTRICAL SAFETY ANALYZER2012-10-11
USK110429PROSIM 4, PROSIM 6, PROSIM 82011-09-02
CA14641VICTOREEN DOUBLE CHECKClass II

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