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Cancer Diagnostics, Inc.

USA · Durham

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 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

46listed device types

Class I 45Class II 1Class III 0

plus 60 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

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 States60 registration records, 1 510(k), 0 PMA, 15 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Cancer Diagnostics, Inc. · ANATECH division of Cancer Diagnostics, Inc. · SIENNA CANCER DIAGNOSTICS LIMITED · Cancer Diagnostics

FDA 510(k) clearances by year

12010 · K092330

FDA listed device types

showing 8 of 46

Immunohistochemistry Reagents And Kits 1Hematoxylin Mayer'S 1Mucicarmine 1Slides, Microscope 1Blade, Scalpel 1Cassettes, Tissue 1Punch, Surgical 1Stains, Dye Solution 1

Market	Identifier	Name	Class / date
US	K092330	OC-SENSOR DIANA IFOB TEST	2010-01-08
SA	ME0000008217SFDAA00001	KATANA	—

Cancer Diagnostics, 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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