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Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Meth…
EUDAMEDClass IVD General (EU MDR)
Ref 76H50T
Identity
- Trade Name
- Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 76H50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-76H50TXL EUDAMED
- Basic UDI-DI
- B-76H50TXL EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Beta-2 Microglobulin (β2-MG) Assay Kit (Latex-enhanced Immunoturbidimetric Meth… by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in…
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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-76H50TXL | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED df4d424b-f2b9-4af9-81ca-ceca51e98c91 61 fields · synced Jun 19, 2026