Identity
- Trade Name
- TMB Substrate EUDAMED
- Device Name
- MosaiQ System Reagents EUDAMED
- Model / Reference
- 155050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640327465125 EUDAMED
- Basic UDI-DI
- 764032746MOSAIQSYSTEMVQ EUDAMED
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
TMB Substrate 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 | 764032746MOSAIQSYSTEMVQ | 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 7dbe1eb9-5879-41b9-b6e4-635257f3d40d 61 fields · synced Jun 19, 2026