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Α1-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3004649Model R1: 4x50mL, R2: 2x25mL, Calibration sample: 1x1mLRef 3009786Model R1: 4x50mL, R2: 2x25mL, Control: 2x1mLRef 3021523Model R1: 4x50mL, R2: 2x25mLRef 3009785Model R1: 4x50mL, R2: 2x25mL, Calibration sample: 1x1mL, Control: 2x1mL
Identity
- Trade Name
- α1-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Device Name
- α1-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 2x25mL, Calibration sample: 1x1mL EUDAMED3004649 EUDAMEDR1: 4x50mL, R2: 2x25mL, Control: 2x1mL EUDAMED3009786 EUDAMEDR1: 4x50mL, R2: 2x25mL EUDAMED3021523 EUDAMEDR1: 4x50mL, R2: 2x25mL, Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3009785 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259432 EUDAMED06942202259425 EUDAMED06925794592033 EUDAMED06942202246630 EUDAMED
- Basic UDI-DI
- B-06942202259432 EUDAMEDB-06942202259425 EUDAMEDB-06925794592033 EUDAMEDB-06942202246630 EUDAMED
- EMDN Code
- W0102019004 A1-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
Animal Tissues
Yes
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
Α1-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06942202259432 | 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 f9a2f256-64b6-4cb9-be95-b4c08ce496ec 61 fields · synced Jul 28, 2026
- EUDAMED b21fdcf9-2089-4925-9794-d1904872444c 61 fields · synced May 18, 2026
- EUDAMED 94dea1e6-dbbd-481f-aff4-6fdb8f6a9f85 61 fields · synced May 18, 2026
- EUDAMED bbdbcc36-4b9e-4391-a31d-59229d2244b7 61 fields · synced May 18, 2026