Identity
- Trade Name
- MosaiQ® AiPlex CTD Quality controls EUDAMED
- Device Name
- MosaiQ® AiPlex CTD Quality controls EUDAMED
- Model / Reference
- 132001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640327462025 EUDAMED
- Basic UDI-DI
- 764032746AIPLEXQCZU EUDAMED
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
New Device
No
EUDAMED
MosaiQ® AiPlex CTD Quality controls 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 | 764032746AIPLEXQCZU | 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 f4b369e5-14ce-46e0-9133-78a52f7173c6 61 fields · synced Jul 8, 2026