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NANO-DITECH CORPORATION

USA · Cranbury

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Taiwan, South Korea, Israel, Russia — 5 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

31listed device types

Class I 6Class II 22Class III 0unclassified 3

plus 28 registration records and 8 510(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

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Business type not stated 1IVD import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

4active registrations

Class 2a 3Class 3 1

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 States28 registration records, 8 510(k), 0 PMA

Manufacturer names merged into this page: NANO-DITECH CORPORATION

FDA 510(k) clearances by year

12005 · K050594

12006 · K050975

22010 · K102441

22024 · K240280

12025 · K243561

12026 · K252283

FDA listed device types

showing 8 of 31

Chromatographic Separation, Cpk Isoenzymes 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings 1Devices Detecting Influenza A, B, And C Virus Antigens 1Thin Layer Chromatography, Methamphetamine 1System, Test, C-Reactive Protein 1Test, Natriuretic Peptide 1

Market	Identifier	Name	Class / date
US	K252283	Nano-Check Influenza A+B Test	2026-01-15
US	K243561	Nano-Check Influenza+COVID-19 Dual Test	2025-06-17
US	K240280	Nano-Check RSV Test	2024-07-30

NANO-DITECH CORPORATION

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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