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MosaiQ® AiPlex CTDplus
EUDAMEDClass B (EU MDR)
Ref 160005Model 1x250, 4x85, 1x85Ref 160003Ref 160009
Identity
- Trade Name
- MosaiQ® AiPlex CTDplus EUDAMED
- Device Name
- MosaiQ® AiPlex CTDplus EUDAMED
- Model / Reference
- 1x250, 4x85, 1x85 EUDAMED160005 EUDAMED160003 EUDAMED160009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640327462087 EUDAMED07640327462070 EUDAMED07640327462308 EUDAMED
- Basic UDI-DI
- 764032746CTDPLUSMAGH5 EUDAMED
- Direct Marketing DI
- 07640327462117 EUDAMED07640327462070 EUDAMED07640327462308 EUDAMED
- EMDN Code
- W0102100199 AUTOIMMUNE CONNECTIVE TISSUE DISEASES TESTING - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 CTDplus 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 | 764032746CTDPLUSMAGH5 | 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 (4)
- EUDAMED 45e04f7a-3490-4da0-a97b-cf414b2b0667 61 fields · synced Jul 30, 2026
- EUDAMED 435f0091-641e-4f29-8553-7eb0492a62c8 61 fields · synced May 17, 2026
- EUDAMED b8e9ce22-ed95-4a30-a88f-8b1111f3c1fb 61 fields · synced May 18, 2026
- EUDAMED abd991ce-8790-4a4a-9718-0832b18d20ce 61 fields · synced Jul 9, 2026