Identity
- Trade Name
- Sheath EUDAMED
- Device Name
- Urinalysis Reagent EUDAMED
- Model / Reference
- 3020856 EUDAMED3009159 EUDAMED3019895 EUDAMED3019968 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794587473 EUDAMED06925794516336 EUDAMED06925794577313 EUDAMED06925794577399 EUDAMED
- Basic UDI-DI
- 69257945W010106020302R0FD EUDAMED
- EMDN Code
- W010106020302 URINE SEDIMENT TEST KIT (AUTOMATED) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium EUDAMEDAustria 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 72696dbf-1b53-495e-8b38-70d39dc5da21 61 fields · synced Jul 17, 2026
- EUDAMED ceded0d0-fe41-4fe5-8a24-ef90d66cb4cc 61 fields · synced May 19, 2026
- EUDAMED 59905b33-ba70-4fd3-8cc6-b3119f83096b 61 fields · synced Jul 17, 2026
- EUDAMED 869c98c8-0f90-4450-9cbf-64c348a7ab39 61 fields · synced Jul 17, 2026