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Beta2-microglobulin urine
EUDAMEDClass IVD General (EU MDR)
Ref BUDGX-H00
by Diagam S.A.
Identity
- Trade Name
- Beta2-microglobulin urine EUDAMED
- Device Name
- Beta2-microglobulin urine EUDAMED
- Model / Reference
- BUDGX-H00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168005692 EUDAMED
- Basic UDI-DI
- B-05415168005692 EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Category: Beta-2-microglobulin IVD, reagent
Beta2-microglobulin urine by Diagam 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
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · IVD General
- Omlipo BMG Kit — Goldsite Diagnostics Inc. · IVD General
- Optilite® Beta-2 Microglobulin Urine Control Pack — The Binding Site Group Ltd. · Class B
- ReLIA — ReLIA Biotechnologies (Jiangsu), Inc. · 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-05415168005692 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (1)
- EUDAMED c40f8150-3dbf-458d-8c8f-34f46594c1ca 61 fields · synced Jun 18, 2026