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CHEMATICS, INC.

USA · North Webster

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

4listed device types

Class I 2Class II 2Class III 0

plus 5 registration records and 2 510(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

4active device licences

Class II 3Class III 1

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 States5 registration records, 2 510(k), 0 PMA

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: CHEMATICS, INC. · CHEMATICS INC.

FDA 510(k) clearances by year

12012 · K121256

12013 · K121247

FDA listed device types

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method 1Glucose Oxidase, Glucose 1Container, Specimen Mailer And Storage, Non-Sterile 1Enzymatic Esterase--Oxidase, Cholesterol 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K121247	ALCO-SCREEN	2013-03-22
US	K121256	ALCO-SCREEN 02	2012-09-12
CA	83806	CHEMCARDS BRAND CHOLESTEROL TEST	Class II
CA	85784	CHEMCARD GLUCOSE TEST	Class III
CA	98189	ALCO-SCREEN	Class II

CHEMATICS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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