Home›Canada›BIOMEDICA DIAGNOSTICS INC.

BIOMEDICA DIAGNOSTICS INC.

Canada · Windsor

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, 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

11listed device types

Class I 1Class II 10Class III 0

plus 17 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

3 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 2

32 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 2 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 1 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 States17 registration records, 0 510(k), 0 PMA, 12 excluded

Brazil1 confirmed, 10 excluded

Canada2 confirmed, 3 excluded

Manufacturer names merged into this page: BIOMEDICA DIAGNOSTICS INC. · BIOMEDICA DIAGNOSTICS INC

FDA listed device types

showing 8 of 11

Antithrombin Iii Quantitation 1Test, Qualitative And Quantitative Factor Deficiency 1Test, Time, Partial Thromboplastin 1Plasma, Coagulation Control 1Control, Plasma, Abnormal 1Assay, Heparin 1Activated Partial Thromboplastin 1Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control 1

Market	Identifier	Name	Class / date
BR	80252400006	FIBRINOGÊNIO CLOT	Class II
CA	74528	ACTICLOT LA COMPLETE	Class II
CA	28622	BIOMEDICA CLINICAL CHEMISTRY ANALYZER, BMD 1940 PLUS	Class II

BIOMEDICA DIAGNOSTICS INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies