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Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay）
EUDAMEDClass IVD General (EU MDR)
Ref 3023568Model R1: 1x40mL, R2: 1x10mL，Calibration sample: 1mLRef 3021199Ref 3024317Model Type B：5×1mL（5levels）
Identity
- Trade Name
- β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMEDβ2-Microglobulin Calibrator EUDAMED
- Device Name
- β2-MICROGLOBULIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMEDβ2-Microglobulin Calibrator EUDAMED
- Model / Reference
- R1: 1x40mL, R2: 1x10mL，Calibration sample: 1mL EUDAMED3023568 EUDAMED3021199 EUDAMEDType B：5×1mL（5levels） EUDAMED3024317 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202215841 EUDAMED06942202259456 EUDAMED06942202223280 EUDAMED
- Basic UDI-DI
- B-06942202215841 EUDAMEDB-06942202259456 EUDAMEDB-06942202223280 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - OTHER EUDAMEDW0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
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
Β2-Microglobulin Reagent Kit（latex Enhanced Immunoturbidimetric Assay） 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-06942202215841 | 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 (3)
- EUDAMED a63b4acf-4881-4779-88b2-6bad1c01f369 61 fields · synced Aug 3, 2026
- EUDAMED 24bee443-ea5b-4d20-844a-6b04c10ab661 61 fields · synced May 18, 2026
- EUDAMED 089eec4d-ef00-4a25-9a82-5e484f11fd5c 61 fields · synced Aug 3, 2026