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Polymer Technology Systems, Inc.

USA · Whitestown

✓ 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

11listed device types

Class I 8Class II 3Class III 0

plus 22 registration records and 58 510(k), 97 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

28registered devices

Class I 2Class II 26

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

5 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 States22 registration records, 58 510(k), 97 PMA, 40 excluded

Brazil28 confirmed, 8 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: Polymer Technology Systems · POLYMER TECHNOLOGY SYSTEMS, INC. · POLYMER TECHNOLOGY SYSTEMS, INC

FDA 510(k) clearances by year

11985

11989

21991

41992

21994

11995

21997

41998

41999

62000

82001

32002

22004

12006

32007

12014

22015

22016

12018

12022

FDA listed device types

showing 8 of 11

Tube, Collection, Capillary Blood 1Lipoprotein, High Density, Hdl, Over The Counter 1Test, Triglycerides, Over The Counter 1Enzymatic Esterase--Oxidase, Cholesterol 1Multi-Analyte Controls, All Kinds (Assayed) 1Ldl & Vldl Precipitation, Hdl 1Colorimetric Method, Triglycerides 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K193406	CardioChek Plus Test System; CardioChek Plus Home Test System	2022-02-26
US	K182781	PTS Professional Chemistry Kit	2018-12-21
US	K151545	CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System	2016-12-22
BR	10230730155	CHOL + HDL + GLU Test Strips	Class II
BR	10230730171	CardioChek Plus	Class II
BR	10230730157	Lipid Panel Test Strips	Class II

Polymer Technology Systems, 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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