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β2-Microglobulin Detection Kit (Chemiluminescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref 3010670Model 1×50 Tests/kitRef 3010690Model 1×100 Tests/kit
Identity
- Trade Name
- β2-Microglobulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Device Name
- β2-Microglobulin Detection Kit (Chemiluminescence Immunoassay) EUDAMED
- Model / Reference
- 1×50 Tests/kit EUDAMED3010670 EUDAMED1×100 Tests/kit EUDAMED3010690 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794518248 EUDAMED06925794518255 EUDAMED
- Basic UDI-DI
- B-06925794518248 EUDAMEDB-06925794518255 EUDAMED
- EMDN Code
- W0102019099 SPECIFIC PROTEINS - 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 Detection Kit (Chemiluminescence Immunoassay) 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-06925794518248 | 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 (2)
- EUDAMED 16c573be-f188-45fb-b679-9794ee2b6940 61 fields · synced Jul 30, 2026
- EUDAMED 7120e7af-554e-4667-935c-359e75fd6d8d 61 fields · synced May 19, 2026