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Urine Sediment Analyzer Reagent Sheath
EUDAMEDClass A (EU MDR)
Ref 3019031Ref 3019954Ref FUS-560
Identity
- Trade Name
- Urine Sediment Analyzer Reagent Sheath EUDAMEDUrine Sediment Analyzer EUDAMED
- Device Name
- Urinalysis Reagent EUDAMEDUrine Sediment Analyzer EUDAMED
- Model / Reference
- 3019031 EUDAMED3019954 EUDAMEDFUS-560 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794511706 EUDAMED06925794577320 EUDAMED06942202237560 EUDAMED06942202226908 EUDAMED
- Basic UDI-DI
- 69257945W010106020302R0FD EUDAMEDB-06942202237560 EUDAMEDB-06942202226908 EUDAMED
- EMDN Code
- W010106020302 URINE SEDIMENT TEST KIT (AUTOMATED) EUDAMEDW0201010202 URINARY SEDIMENT DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Hungary 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
Urine Sediment Analyzer Reagent Sheath 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 (4)
- EUDAMED 0702ef44-6896-4378-a9ee-af9a4d72765d 61 fields · synced Jul 16, 2026
- EUDAMED bee84acd-5f79-487c-bcb8-bca3972af33a 61 fields · synced Jul 11, 2026
- EUDAMED c9b5393c-e676-4b0d-b8ad-2190821bb84e 61 fields · synced Jul 12, 2026
- EUDAMED a3dd3f50-6a8a-4ac7-96c4-27abfe29d772 61 fields · synced Jul 16, 2026