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bioLytical Laboratories Inc.

Canada · Richmond BC · www.biolytical.com

✓ Record-verifiedregistrations found in 6 marketsEU SRN CA-MF-000023304

This company has registrations in European Union, United States, United Kingdom, Canada, Australia, Israel — 6 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

52UDI-DI device records

ivd-annex-ii-list-a 52

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 1Class III 1

plus 2 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

7registered device records

IVD general 1IVD Annex II List A 5IVD Devices for Self-Testing 1

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

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 3 1IVD Class 4 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 Union52 raw hits, 0 excluded, 52 confirmed

United States2 registration records, 0 510(k), 0 PMA

United Kingdom7 confirmed, 0 excluded

Manufacturer names merged into this page: BIOLYTICAL LABORATORIES INC.

Regulatory identity

EU manufacturer SRN: CA-MF-000023304
EU authorised representative: Emergo Europe B.V.
UK responsible person: Qarad UK Ltd.

Business registration

Corporation number: 3960773
Registration status: Active
Legal form: Canada Business Corporations Act
Incorporated: 2002-01-02
Registered address: 1200 Waterfront Centre, VANCOUVER, BC, V6C 3L6

Business registration data from Corporations Canada, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

Market	Identifier	Name	Class / date
EU	00686597202173	INSTI HIV-1/HIV-2 ANTIBODY TEST	ivd-annex-ii-list-a
EU	00686597200414	INSTI HIV-1/HIV-2 ANTIBODY TEST	ivd-annex-ii-list-a
EU	00686597010501	INSTI HIV Self Test (no pipette variant, packaged in a box)	ivd-annex-ii-list-a
EU	00686597010563	INSTI HIV Self Test (no pipette variant, packaged in a box)	ivd-annex-ii-list-a
UK	41973	INSTI HCV Test Controls	IVD Annex II List A
UK	30829	INSTI HCV Antibody Test	IVD Annex II List A
UK	48456	INSTI HIV Test Controls	IVD Annex II List A

bioLytical Laboratories Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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