Identity
- Trade Name
- Snibe Maglumi X8 Analyzer Interface Module EUDAMED
- Device Name
- Buffer, TCA EUDAMED
- Model / Reference
- 952339 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438153007326 EUDAMED
- Basic UDI-DI
- 6438153BU0001138F EUDAMED
- Direct Marketing DI
- 06438153007326 EUDAMED
- EMDN Code
- W02060101 AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Yes
EUDAMED
New Device
No
EUDAMED
Snibe Maglumi X8 Analyzer Interface Module by Thermo Fisher Scientific Oy — 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 | 6438153BU0001138F | Class A | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (1)
- EUDAMED c16eda09-3f49-4a36-809a-73a17a0543f1 61 fields · synced Jul 26, 2026