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POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.

USA · Cortlandt Manor

✓ 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

23listed device types

Class I 8Class II 13Class III 2

plus 29 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 1Class III 1

12 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 States29 registration records, 1 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. · POLYMEDCO INC., POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC · POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC,

Same-named companies — This database also contains companies with near-identical names: POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC, Polymedco Cancer Diagnostics, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12010 · K092330

FDA listed device types

showing 8 of 23

Automated Occult Blood Analyzer 1Myoglobin, Antigen, Antiserum, Control 1Visual, Pregnancy Hcg, Prescription Use 1Reagent, Occult Blood 1Calibrator, Secondary 1Fibrin Split Products 1Immunoassay Method, Troponin Subunit 1Devices Detecting Influenza A, B, And C Virus Antigens 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K092330	OC-SENSOR DIANA IFOB TEST	2010-01-08
BR	80102512411	Reagente Buffer OC-Auto® Polymedco	Class I
BR	80102512539	FAMÍLIA DE ANALISADORES DE SANGUE OCULTO EM FEZES AUTOMATIZADO	Class II
BR	80102512427	Frascos de Amostras para OC-Auto® Polymedco	Class I
CA	61904	BTA STAT TEST	Class III
CA	78963	OC-LIGHT MANUAL IFOBT	Class II

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.

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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