Identity
- Trade Name
- MosaiQ® AiPlex VAS EUDAMED
- Device Name
- MosaiQ® AiPlex VAS EUDAMED
- Model / Reference
- 1x250, 4x85 EUDAMED160041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640327462209 EUDAMED
- Basic UDI-DI
- 764032746AIPLEXVASMAG7P EUDAMED
- Direct Marketing DI
- 07640327462193 EUDAMED
- EMDN Code
- W0102100499 VASCULITIS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
MosaiQ® AiPlex VAS by AliveDx Suisse SA — Class B — 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 | 764032746AIPLEXVASMAG7P | Class B | 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 9bc1139a-a5d9-4085-922c-42e994f5e111 61 fields · synced Jul 21, 2026