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Home›USA›INFRARED LABORATORY SYSTEMS LLC DBA SYNERMED INTERNATIONAL, INC.

INFRARED LABORATORY SYSTEMS LLC DBA SYNERMED INTERNATIONAL, INC.

USA · Westfield
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
41listed device types
Class I 18Class II 23Class III 0
plus 38 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 2
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
6active device licences
Class II 6
33 including historic records
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 States38 registration records, 3 510(k), 0 PMA, 2 excluded
Brazil2 confirmed, 0 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: Infrared Laboratory Systems dba SYNERMED · INFRARED LABORATORY SYSTEMS LLC DBA SYNERMED INTERNATIONAL, INC. · SYNERMED INTERNATIONAL INC.
Same-named companies — This database also contains companies with near-identical names: Infrared Laboratory Systems, LLC (Dba Synermed). Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Westfield

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

12016 · K153692
22018 · K181201

FDA listed device types

showing 8 of 41
System, Test, Sodium, Enzymatic Method 1Alkaline Picrate, Colorimetry, Creatinine 1Calibrator, Secondary 1Electrode, Ion-Specific, Chloride 1Test, System, Potassium, Enzymatic Method 1Catalytic Methods, Amylase 1Biuret (Colorimetric), Total Protein 1Calibrators, Drug Mixture 1

Registration details (sample)

MarketIdentifierNameClass / date
USK181201Synermed ISE Reagents2018-07-10
USK172416Synermed Opiate Enzyme Immunoassay2018-04-19
USK153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer2016-06-24
BR10438910033KIT PARA PROCESSO DE CITOLOGIA POR CAMADA DELGADAClass I
BR10438910034LIQUIDO CONSERVANTE DE CITOLOGIA GERALClass I
CA71731IR CAL IIClass II
CA71732BILIRUBIN REAGENTClass II
CA71733CREATININE REAGENTSClass II

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