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Kamiya Biomedical Company LLC

✓ Record-verifiedregistrations found in 7 marketsEU SRN US-MF-000002769

This company has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Australia, Israel — 7 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

77UDI-DI device records

IVD B 3IVD general 74

USUnited StatesFDA openFDA

33listed device types

Class I 10Class II 23Class III 0

plus 41 registration records and 46 510(k)

UKUnited KingdomMHRA PARD

57registered device records

IVD general 57

BRBrazilANVISA

1registered devices

Class II 1

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

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 2 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

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.

European Union77 raw hits, 0 excluded, 77 confirmed

United States41 registration records, 46 510(k), 0 PMA, 2 excluded

United Kingdom57 confirmed, 0 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: KAMIYA BIOMEDICAL COMPANY LLC · KAMIYA BIOMEDICAL COMPANY

Regulatory identity

EU manufacturer SRN: US-MF-000002769
EU authorised representative: Advena Limited
UK responsible person: Oxford Biosystems Ltd

FDA 510(k) clearances by year

11991

21998

241999

22000

42001

42002

22003

12004

12005

22010

12012

12020

12025

FDA listed device types

showing 8 of 33

Calibrator, Secondary 1Test, Cystatin C 1Calibrator, Primary 1System, Test, Rheumatoid Factor 1Haptoglobin, Antigen, Antiserum, Control 1Test, Fibrinogen 1Alpha-1-Antitrypsin, Antigen, Antiserum, Control 1Ferritin, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00816426021013	Coagulation Control	IVD general
EU	00816426020764	Factor XIII Calibrator	IVD general
EU	00816426020535	Factor XIII	IVD general
EU	00816426021587	K-ASSAY KL-6 Control (Ver.2)	IVD general
UK	53924	Alpha-1 Microglobulin Reagent	IVD general
UK	53444	Apo AI Reagent	IVD general
UK	53446	Apo AII Reagent	IVD general
US	K242170	K-ASSAY CRP (Ver.2)	2025-04-18
US	K192727	K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)	2020-05-20
US	K121232	K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR	2012-05-24
BR	80102511690	FAMÍLIA K-ASSAY® FACTOR XIII	Class II

Kamiya Biomedical Company LLC

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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