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beta2-MICROGLOBULIN
EUDAMEDClass IVD General (EU MDR)
Ref 23925Ref 31925Ref 31122
Identity
- Device Name
- beta2-MICROGLOBULIN EUDAMEDbeta2-MICROGLOBULIN STANDARD EUDAMED
- Model / Reference
- 23925 EUDAMED31925 EUDAMED31122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287108286 EUDAMED08435287119251 EUDAMED08435287111224 EUDAMED
- Basic UDI-DI
- B-08435287108286 EUDAMEDB-08435287119251 EUDAMEDB-08435287111224 EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMEDW0102152203 SPECIFIC PROTEIN STANDARDS AND CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
Category: Beta-2-microglobulin IVD, reagent
beta2-MICROGLOBULIN by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Beta-2-microglobulin IVD, reagent.
- Beta 2 Microglobulin (β2-MG) Test Kit (Immunofluorescence Method) — WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- Beta2-microglobulin — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- 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-08435287108286 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (3)
- EUDAMED 25cf025f-db5b-4692-862b-a130bea711a4 61 fields · synced Jul 13, 2026
- EUDAMED 97002d4b-7652-4045-9f57-7c3230432419 61 fields · synced May 17, 2026
- EUDAMED b3f0fbf2-baa6-4dba-b307-8075780e67b8 61 fields · synced May 18, 2026