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Simplitude ByMe
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref P002514A1-10Model Galileo Platform
Identity
- Trade Name
- Simplitude ByMe EUDAMED
- Device Name
- HIV Self Test EUDAMED
- Model / Reference
- Galileo Platform EUDAMEDP002514A1-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09349609000204 EUDAMED
- Basic UDI-DI
- B-09349609000204 EUDAMED
- EMDN Code
- W0105030402 HIV MULTIPLE ANTIBODY EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Simplitude ByMe by Atomo Diagnostics Limited — Class IVD Annex II List A — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-09349609000204 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Atomo Diagnostics Limited
- EUDAMED SRN
- AU-MF-000024146
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED bc75a179-4768-4a25-a248-6c6d76dc50ab 61 fields · synced Jun 18, 2026