Identity
- Trade Name
- FUS Series Urinalysis Hybrid Sheath II EUDAMED
- Device Name
- Urinalysis Reagent EUDAMED
- Model / Reference
- 3009269 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794516503 EUDAMED
- Basic UDI-DI
- 69257945W010106020302R0FD EUDAMED
- EMDN Code
- W010106020302 URINE SEDIMENT TEST KIT (AUTOMATED) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Czechia 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
FUS Series Urinalysis Hybrid Sheath II 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 800ce99d-d734-4d55-ac80-5df433a9e18e 61 fields · synced Jun 18, 2026