Identity
- Trade Name
- MosaiQ 125 EUDAMED
- Device Name
- MosaiQ 125 EUDAMED
- Model / Reference
- 126001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640327466016 EUDAMED
- Basic UDI-DI
- 764032746MOSAIQJH EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
MosaiQ 125 by AliveDx Suisse SA — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 764032746MOSAIQJH | Class A | Active |
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Manufacturer
- Manufacturer
- AliveDx Suisse SA
- EUDAMED SRN
- CH-MF-000024025
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 166f5af2-bb0a-4d94-a150-7fad4f2f0454 61 fields · synced Jul 22, 2026