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β2 Microglobulin (β2-MG) Detection Kit（Magnetic Solid Phase Chemiluminescent Im…
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/kit（DR1079-2）Model 100 Tests/kitRef 50 Tests/kit（DR1079-1）Model 50 Tests/kit
Identity
- Trade Name
- β2 Microglobulin (β2-MG) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay) EUDAMED
- Device Name
- β2 Microglobulin (β2-MG) Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 100 Tests/kit EUDAMED100 Tests/kit（DR1079-2） EUDAMED50 Tests/kit EUDAMED50 Tests/kit（DR1079-1） EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974969981769 EUDAMED06974969981196 EUDAMED
- Basic UDI-DI
- B-06974969981769 EUDAMEDB-06974969981196 EUDAMED
- EMDN Code
- W01021299 ORGAN FUNCTION ASSAYS - OTHER EUDAMEDW0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 (β2-MG) Detection Kit（Magnetic Solid Phase Chemiluminescent Im… by Biobase Diagnostic Technology (Shandong) Co., Ltd. — Class IVD General…
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-06974969981769 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biobase Diagnostic Technology (Shandong) Co., Ltd.
- EUDAMED SRN
- CN-MF-000025964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED 5db8923e-58af-4ede-a9a2-ff1d494351c9 61 fields · synced Oct 6, 2026
- EUDAMED 31f30e9c-5e0b-4974-abb1-db03055e2e4f 61 fields · synced May 17, 2026
- EUDAMED bc1ddc7c-16d8-4ce9-99bf-7e364f711778 61 fields · synced Jul 17, 2026