HomeCanadaARTRON LABORATORIES INC

ARTRON LABORATORIES INC

Canada · Burnaby BC · www.artronlab.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CA-MF-000028974

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Israel — 8 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
68UDI-DI device records
IVD C 2IVD D 8IVD general 10ivd-annex-ii-list-a 4ivd-devices-self-testing 44
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 2 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
10registered device records
Class D – Self-testing or Near-patient Testing 4IVD Devices for Self-Testing 6
BRBrazilANVISA
0registered devices
10 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
4active device licences
Class II 4
65 including historic records
TWTaiwanTFDA
6valid device licences
Class I 4Class II 2
SGSingaporeHSA SMDR
4device registrations
CLASS B 4
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 Union68 raw hits, 0 excluded, 68 confirmed
United States2 registration records, 1 510(k), 0 PMA
United Kingdom10 confirmed, 0 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: ARTRON LABORATORIES INC.

Regulatory identity

EU manufacturer SRN
CA-MF-000028974
EU authorised representative
MedNet EC-REP GmbH
UK responsible person
SUNGO Certification Company Limited

Company information

Country
Canada
City
Burnaby BC
Website
www.artronlab.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsPoint-of-care & near-patient testing

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
ARTRON LABORATORIES INC.
LEI
549300883RE115J3LD19
Registration status
Active
Legal form
Company (includes community contribution company and unlimited liability company
Registered address
3938 North Fraser Way, Burnaby, V5J 5H6
Registration authority
Corporate Registry (Province of British Columbia), no. BC0706255
Registry record updated
2023-08-08

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

FDA 510(k) clearances by year

12006 · K060019

FDA listed device types

Test, Luteinizing Hormone (Lh), Over The Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Visual, Pregnancy Hcg, Prescription Use 1

Registration details (sample)

MarketIdentifierNameClass / date
EU00628347568290MIRATECH Luteinizing Hormone Tests for self-testingivd-devices-self-testing
EU00628347566227LifeClues Ovulation Testivd-devices-self-testing
EU00628347566210LifeClues Ovulation Testivd-devices-self-testing
EU00628347566203LifeClues Ovulation Testivd-devices-self-testing
UK65841Follicle-Stimulating Hormone (FSH) Menopause Test Kit For self-testingIVD Devices for Self-Testing
UK65947Luteinizing Hormone (LH) Test For self-testingIVD Devices for Self-Testing
UK65454COVID-19 Antigen Home TestIVD Devices for Self-Testing
USK060019ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)2006-02-17
CA80688C-REACTIVE PROTEIN (CRP) TEST DEVICE (WHOLE BLOOD)Class II
CA82759OXYCODONE (OXY) TEST KITClass II
CA101902ARTRON ONE STEP C-REACTIVE PROTEIN (CRP) SEMI-QUANTITATIVE TESTClass II

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