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FUS Series Urinalysis Hybrid Sheath II
EUDAMEDClass A (EU MDR)
Ref 3009267 Ref FUS-3000Plus Ref 3019943Ref FUS-2000
Identity
- Trade Name
- FUS Series Urinalysis Hybrid Sheath II EUDAMEDUrinalysis Hybrid EUDAMED
- Device Name
- Urinalysis Reagent EUDAMEDUrinalysis Hybrid EUDAMED
- Model / Reference
- 3009267 EUDAMEDFUS-3000Plus EUDAMED3019943 EUDAMEDFUS-2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794516480 EUDAMED06925794515032 EUDAMED06925794577344 EUDAMED06925794576309 EUDAMED06925794504562 EUDAMED
- Basic UDI-DI
- 69257945W010106020302R0FD EUDAMEDB-06925794515032 EUDAMEDB-06925794576309 EUDAMEDB-06925794504562 EUDAMED
- EMDN Code
- W010106020302 URINE SEDIMENT TEST KIT (AUTOMATED) EUDAMEDW020101020103 AUTOMATED URINE ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Czechia EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
New Device
No
EUDAMED
FUS Series Urinalysis Hybrid Sheath II by Dirui Industrial Co., Ltd — Class A — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69257945W010106020302R0FD | Class A | Active |
| 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 (5)
- EUDAMED 2819eb0f-993d-4f05-b167-2b9abc1b8cc1 61 fields · synced Jul 17, 2026
- EUDAMED cfe68b6e-78b5-4ebe-9304-9309a8a0001c 61 fields · synced Jun 20, 2026
- EUDAMED 692a514d-2545-4e3f-aeba-33230fe871c1 61 fields · synced Jul 9, 2026
- EUDAMED fbdaec1b-6176-4042-b2d2-9011aaae8eb1 61 fields · synced Jul 15, 2026
- EUDAMED afd64fa0-5fcb-4835-8654-9c62134135b0 61 fields · synced Jul 17, 2026