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KRONUS, INC.

USA · Star

✓ 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

10listed device types

Class I 0Class II 10Class III 0

plus 21 registration records and 9 510(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

9active device licences

Class II 9

20 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 States21 registration records, 9 510(k), 0 PMA, 1 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: KRONUS, INC.

FDA 510(k) clearances by year

21989 · K894203

21992 · K915428

22016 · K161951

22018 · K180607

12023 · K220085

FDA listed device types

showing 8 of 10

Aquaporin-4 Autoantibody 1Zinc Transporter 8 Auto-Antibody 1System, Test, Thyroglobulin 121-Hydroxylase Antibody (21-Ohab) 1Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking 1Voltage Gated Calcium Channel (Vgcc) Antibody Assay 1Tyrosine Phosphatase (Ia-2) Autoantibody Assay 1Autoantibodies, Glutamic Acid Decarboxylase (Gad) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220085	KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit	2023-08-24
US	K180607	Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit	2018-11-23
US	K171731	KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit	2018-01-19
CA	1406	THYROGLOBULIN ANTIBODY ELISA KIT	Class II
CA	1408	THYROID PEROXIDASE (TPO) ANTIBODY ELISA KIT	Class II
CA	1409	THYROGLOBULIN ANTIBODY RADIOIMMUNOASSAY KIT	Class II

KRONUS, 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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