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Β2-Microglobulin ELISA Kit
EUDAMEDClass IVD General (EU MDR)
Ref CAN-B-4300Model 96 Tests
Identity
- Device Name
- Β2-Microglobulin ELISA Kit EUDAMED
- Model / Reference
- 96 Tests EUDAMEDCAN-B-4300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++B261CANB43009F EUDAMED
- Basic UDI-DI
- B-++B261CANB43009F EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Category: Beta-2-microglobulin IVD, reagent
Β2-Microglobulin ELISA Kit by Diagnostics Biochem Canada Inc — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Beta-2-microglobulin IVD, reagent.
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- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · 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-++B261CANB43009F | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagnostics Biochem Canada Inc.
- EUDAMED SRN
- CA-MF-000032449
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED d09b256b-6cd4-4f01-ab63-45849766c502 61 fields · synced Jul 14, 2026
- EUDAMED a3d79a95-577e-4e5c-b15c-d3f93683ed7b 61 fields · synced Jul 14, 2026