Identity
- Trade Name
- Maybe Baby EUDAMED
- Device Name
- Maybe Baby EUDAMED
- Model / Reference
- MB 00.00.00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09317039000460 EUDAMED
- Basic UDI-DI
- B-09317039000460 EUDAMED
- EMDN Code
- W0102160399 FERTILITY/PREGNANCY RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Maybe Baby by Optix Doo Beograd-Zemun — Class IVD devices for self-testing — 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-09317039000460 | Class IVD devices for self-testing | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Optix Doo Beograd-Zemun
- EUDAMED SRN
- RS-MF-000031651
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED 8389c1cb-826b-4c99-9380-5930cd38e2e8 61 fields · synced Jul 23, 2026