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Sign in to claim this brandAtomo Diagnostics Limited
Australia·AU-MF-000024146
Last updated September 18, 2026
About
Atomo Diagnostics Limited is a global leader in the user-centred design of innovative, accurate and reliable rapid diagnostics.
From the manufacturer's own website. Source
What Atomo Diagnostics Limited makes
Atomo Diagnostics Limited manufactures rapid diagnostic tests for HIV, including self-testing devices such as the Atomo HIV Self Test and the Newfoundland HIV Self Test. Their portfolio also includes a rapid HIV screening device called Simplitude ByMe, designed for point-of-care use. Additional products, such as ARST001-02, are part of their infectious disease testing solutions.
These devices fall under the EU In Vitro Diagnostic Medical Device Regulation (IVDR) as Class A devices listed in Annex II List A. They are registered in the EU’s eudamed database. The company is based in Australia.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Atomo Diagnostics Limited manufacture?
Atomo Diagnostics Limited manufactures rapid diagnostic tests for HIV, including self-testing devices like the Atomo HIV Self Test and Newfoundland HIV Self Test, as well as point-of-care screening devices such as Simplitude ByMe.
Where is Atomo Diagnostics Limited based?
Atomo Diagnostics Limited is based in Australia, as indicated by the country code AU in their device data.
Which regulatory registries list Atomo Diagnostics Limited's devices?
Atomo Diagnostics Limited's devices are listed in the EU's eudamed database, which is the European database for medical devices.
How are Atomo Diagnostics Limited's devices classified?
Atomo Diagnostics Limited's devices are classified under the EU In Vitro Diagnostic Medical Device Regulation (IVDR) as Class A devices listed in Annex II List A, which applies to self-testing devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Australia
- Address
- Level 1, 3-5, George Street, Leichhardt, Australia
- Website
- www.atomodiagnostics.com/
- facebook.com/atomo.hiv
- [email protected]
- Phone
- +61 2 9099 4750
- PRRC Contact
- Chandra Sukumar
- EUDAMED SRN
- AU-MF-000024146
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Atomo HIV Self Test | ARST001-05 | EUDAMED | IVD Annex II List A | Active |
| Simplitude ByMe | P003948A1-10 | EUDAMED | IVD Annex II List A | Active |
| Atomo HIV Self Test | ARST001-04 | EUDAMED | IVD Annex II List A | Active |
| Newfoundland HIV Self Test | NFLD001-03 | EUDAMED | IVD Annex II List A | Active |
| Simplitude ByMe | P002514A1-10 | EUDAMED | IVD Annex II List A | Active |
| Newfoundland HIV Self Test | NFLD001-02 | EUDAMED | IVD Annex II List A | Active |
| Arst001-02 | ARST001-02 | EUDAMED | IVD Annex II List A | Active |
Related Companies
Authorised Representatives
- QbD RepS BV BE
Importers
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Notified Bodies
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Authorities
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