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Urea Reagent Kit（enzyme Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3021175Model R1: 4x50mL, R2: 2x25mL，Calibration sample: 2mLRef 3000620Model R1: 2x60mL, R2: 2x15mL, Calibration sample: 2mLRef 3002387Model R1: 4x50mL, R2: 1x50mL，Calibration sample: 2mLRef 3000619Model R1: 4x80mL, R2: 4x20mL, Calibration sample: 2mL
Identity
- Trade Name
- UREA REAGENT KIT（ENZYME METHOD） EUDAMED
- Device Name
- UREA REAGENT KIT（ENZYME METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 2x25mL，Calibration sample: 2mL EUDAMED3021175 EUDAMEDR1: 2x60mL, R2: 2x15mL, Calibration sample: 2mL EUDAMED3000620 EUDAMEDR1: 4x50mL, R2: 1x50mL，Calibration sample: 2mL EUDAMED3002387 EUDAMEDR1: 4x80mL, R2: 4x20mL, Calibration sample: 2mL EUDAMED3000619 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259555 EUDAMED06942202259548 EUDAMED06942202239779 EUDAMED06942202259562 EUDAMED
- Basic UDI-DI
- B-06942202259555 EUDAMEDB-06942202259548 EUDAMEDB-06942202239779 EUDAMEDB-06942202259562 EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Urea Reagent Kit（enzyme Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06942202259555 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 2ea19447-ef3d-478e-89e9-071aa9ddcafb 61 fields · synced Jul 26, 2026
- EUDAMED abb2f1ac-25fd-41a8-8328-e27debc74428 61 fields · synced May 17, 2026
- EUDAMED bd284115-268f-4e33-8184-743a51c469fe 61 fields · synced May 17, 2026
- EUDAMED 1275f6b1-af91-4f8d-9c01-cfe579f28e27 61 fields · synced May 18, 2026