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RESPONSE BIOMEDICAL CORPORATION

Canada · Vancouver

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 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

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 3Class II 4Class III 0

plus 7 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

2active device licences

Class III 2

22 including historic records

TWTaiwanTFDA

7valid device licences

Class II 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 1 1IVD Class 2 2IVD Class 3 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

6active registrations

Class 1 1Class 2a 3Class 2b 1Class 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 States7 registration records, 7 510(k), 0 PMA, 8 excluded

Brazil6 confirmed, 2 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: Response Biomedical Corp. · RESPONSE BIOMEDICAL CORPORATION · RESPONSE BIOMEDICAL CORP.

FDA 510(k) clearances by year

12001 · K012040

22004 · K033745

22008 · K063662

22009 · K093116

FDA listed device types

Myoglobin, Antigen, Antiserum, Control 1Immunoassay Method, Troponin Subunit 1Test, Natriuretic Peptide 1Fluorometric Method, Cpk Or Isoenzymes 1Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus 1Fluorometer, For Clinical Use 1Multi-Analyte Controls, All Kinds (Assayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K093116	MODIFICATION TO: RAMP INFLUENZA A/B ASSAY	2009-10-21
US	K091235	RAMP RSV ASSAY	2009-07-24
US	K063662	RAMP NT-PROBNP ASSAY	2008-07-21
BR	80102512695	RAMP® BNP	Class II
BR	80102512658	RAMP® 200	Class II
BR	80102512659	RAMP® Reader	Class II
CA	89273	RESPONSE READER SYSTEM	Class III
CA	91293	RAMP CARDIAC CONTROLS	Class III

RESPONSE BIOMEDICAL 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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