Identity
- Device Name
- Stop Solution EUDAMED
- Model / Reference
- 00-5007-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120122925072 EUDAMED
- Basic UDI-DI
- 9120122925076R EUDAMED
- Direct Marketing DI
- 09120122925072 EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Stop Solution by MacroArray Diagnostics — 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 | 9120122925076R | Class A | Active |
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Manufacturer
- Manufacturer
- MacroArray Diagnostics
- EUDAMED SRN
- AT-MF-000030541
Sources (1)
- EUDAMED f4c693ac-a43f-414c-a2d2-22fe3e9aa6c0 61 fields · synced Oct 8, 2026