Identity
- Trade Name
- Urine Sediment Analyzer Reagent Sheath EUDAMED
- Device Name
- Urinalysis Reagent EUDAMED
- Model / Reference
- 3018645 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576521 EUDAMED
- Basic UDI-DI
- 69257945W010106020302R0FD EUDAMED
- EMDN Code
- W010106020302 URINE SEDIMENT TEST KIT (AUTOMATED) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Hungary 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
Urine Sediment Analyzer Reagent Sheath by Dirui Industrial Co., Ltd — 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 | 69257945W010106020302R0FD | Class A | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b4129a2f-56be-4bde-8855-6ea713ec36f6 61 fields · synced Jun 17, 2026