Is this your brand? Sign in to claim ownership.
Sign in to claim this brandArtron Laboratories Inc.
Canada·CA-MF-000028974
Last updated September 17, 2026
About
Artron provides accurate rapid Diagnostic Test Kits for quick biomarker detection. Customize lateral flow tests with our components. Explore our solutions now.
From the manufacturer's own website. Source
Information
- Country
- Canada
- Address
- 3938 North Fraser Way , Burnaby, British Columbia, Canada
- Website
- www.artronlab.com/
- facebook.com/ArtronLaboratoriesInc
- [email protected]
- Phone
- +1 604 415 9757
- PRRC Contact
- Danni Huang
- EUDAMED SRN
- CA-MF-000028974
- FDA FEI Number
- 3005445066
- DUNS Number
- —
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acmex Hepatitis C Virus (HCV) Antibody Test | AM02-06-322P25 | EUDAMED | Class D | Active |
| DaysComfort | A01-02-130DC1 | EUDAMED | IVD devices for self-testing | Active |
| THE NEW Test Days | A01-04-130NTD1 | EUDAMED | IVD devices for self-testing | Active |
| AI Bi | A01-02-130AB1 | EUDAMED | IVD devices for self-testing | Active |
| Heltes | A01-04-130HT2 | EUDAMED | IVD devices for self-testing | Active |
| Heltes | A01-02-122HT1 | EUDAMED | IVD devices for self-testing | Active |
| Acmex Hepatitis B Surface Antigen (HBsAg) Test | AM02-01-322P25 | EUDAMED | Class D | Active |
| fertylia | A01-04-130FL2 | EUDAMED | IVD devices for self-testing | Active |
| DaysComfort | A01-02-130DC1*12 | EUDAMED | IVD devices for self-testing | Active |
| Valfast | A01-06-422VF1 | EUDAMED | IVD devices for self-testing | Active |
| Artron Treponema Pallidum (TP) Antibody Test | A02-09-322P | EUDAMED | Class C | Active |
| apotekets | A01-06-422AK1 | EUDAMED | IVD devices for self-testing | Active |
| AI Bi | A01-02-122AB1 | EUDAMED | IVD devices for self-testing | Active |
| Acmex Treponema Pallidum (TP) Antibody Test | AM02-09-322P | EUDAMED | Class C | Active |
| Miratech | A01-03-130MT1 | EUDAMED | IVD devices for self-testing | Active |
| apotekets | A01-04-130AK2 | EUDAMED | IVD devices for self-testing | Active |
| Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test | AM02-07-322P25 | EUDAMED | Class D | Active |
| Heltes | A01-03-113HT5 | EUDAMED | IVD devices for self-testing | Active |
| Accufast | A01-06-422AF1 | EUDAMED | IVD devices for self-testing | Active |
| The New Test Days | A01-03-130NTD2 | EUDAMED | IVD devices for self-testing | Active |
| The New Test Days | A01-02-130NTD1*12 | EUDAMED | IVD devices for self-testing | Active |
| Artron One Step Treponema Pallidum (TP) Antibody Test | A02-09-213 | EUDAMED | IVD General | Active |
| Acmex HIV Ab, HBsAg & HCV Ab (3H) Combo Test (Acmex 3H Combo Test) | AM02-20-322P25 | EUDAMED | Class D | Active |
| Be Sure | A01-06-422BS1 | EUDAMED | IVD devices for self-testing | Active |
| Heltes | A01-02-130HT1 | EUDAMED | IVD devices for self-testing | Active |
| Miratech | A01-02-122MT1 | EUDAMED | IVD devices for self-testing | Active |
| Valfast | A01-03-130VF5 | EUDAMED | IVD devices for self-testing | Active |
| Artron Artron Multi-Drug Dip Card Test | A04-18-140 | EUDAMED | IVD General | Active |
| Arton One-Step Hcg Urinary Pregnancy Test (strip), (cassette), (midstream) | K060019 | FDA 510(k) | Class II | Active |
| Artron Dengue NS1 Antigen Test | A03-22-222 | EUDAMED | IVD General | Active |
| Artron Helicobacter Pylori (HP) Antibody Test | A02-11-222 | EUDAMED | IVD General | Active |
| Artron Fecal Occult Blood (FOB)Test | A05-02-422 | EUDAMED | IVD General | Active |
| Artron HlV, HBsAg & HCV Combo Test | A02-20-222 | EUDAMED | IVD Annex II List A | Active |
| Artron Helicobacter pylori (HP) Antigen Test | A02-11-422 | EUDAMED | IVD General | Active |
| Artron Human Chorionic Gonadotropin (HCG) Test For self-testing(Ultra Sensitivity) | A01-02-130 | EUDAMED | IVD devices for self-testing | Active |
| Artron Human lmmunodeficiency Virus 1/2 (HMl2l Antibody Test | A02-07-222 | EUDAMED | IVD Annex II List A | Active |
| Artron Hepatitis C Virus (HCV) Antibody Test | A02-06-222 | EUDAMED | IVD Annex II List A | Active |
| Artron Onestep Pregnancy Urine Tests for Self- testing (Regular) | A01-01-130 | EUDAMED | IVD devices for self-testing | Active |
| Artron ONE STEP Tuberculosis Antibody (TB Ab) Test | A03-07-222 | EUDAMED | IVD General | Active |
| Artron Procalcitonin (PCT) Test | A03-23-222 | EUDAMED | IVD General | Active |
| Artron Hepatitis B Virus Surface Antigen (HBsAg) Test | A02-01-222 | EUDAMED | IVD Annex II List A | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.