← Back to catalogue
Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref /
Identity
- Device Name
- Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-K90411-040P9 EUDAMED
- Basic UDI-DI
- B-K90411-040P9 EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Beta-2-microglobulin IVD, reagent
Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay) by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed…
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-K90411-040P9 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 1867cdc4-0c30-4967-af86-b67b74c292bd 61 fields · synced Jun 19, 2026