Identity
- Trade Name
- MosaiQ® Allergy Bet v 1 EUDAMED
- Device Name
- MosaiQ Allergy Bet v 1 EUDAMED
- Model / Reference
- 4x85 EUDAMED172001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640327463015 EUDAMED
- Basic UDI-DI
- 764032746BETV1MAGAZINER3 EUDAMED
- Direct Marketing DI
- 07640327463015 EUDAMED
- EMDN Code
- W01020202 IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT 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
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
Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
MosaiQ® Allergy Bet v 1 by AliveDx Suisse SA — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 764032746BETV1MAGAZINER3 | 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 ea8cff00-14a5-4a0c-aa67-75ef08ff0bb0 61 fields · synced Jul 12, 2026