Identity
- Trade Name
- ST-12 EUDAMED
- Device Name
- Urine Sample Transportation Unit EUDAMED
- Model / Reference
- CU845213 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987562511259 EUDAMED
- Basic UDI-DI
- 4987562UrineUnitBL EUDAMED
- EMDN Code
- W020101020180 AUTOMATED URINE ANALYSERS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
New Device
No
EUDAMED
St-12 by Sysmex Corporation — 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 | 4987562UrineUnitBL | Class A | Active |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (1)
- EUDAMED cc8af26d-2505-424d-a3d1-e817cd928c30 61 fields · synced Jun 20, 2026