← Back to catalogue
β2-microglobulin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2145E-75Ref S2145E-50Ref S2145E-25Ref S2145E-150Ref S2145E-200
Identity
- Device Name
- β2-microglobulin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2145E-75 EUDAMEDS2145E-50 EUDAMEDS2145E-25 EUDAMEDS2145E-150 EUDAMEDS2145E-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742529 EUDAMED06955792742512 EUDAMED06955792742505 EUDAMED06955792742543 EUDAMED06955792742550 EUDAMED
- Basic UDI-DI
- B-06955792742529 EUDAMEDB-06955792742512 EUDAMEDB-06955792742505 EUDAMEDB-06955792742543 EUDAMEDB-06955792742550 EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792742529 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED 4e51d6d5-a650-4099-a092-2d34e05232ff 61 fields · synced Aug 2, 2026
- EUDAMED a9dde37a-9cad-41c4-8175-b55e3b314330 61 fields · synced May 17, 2026
- EUDAMED 9275f493-9009-46cd-afbb-31677bd5b1da 61 fields · synced May 18, 2026
- EUDAMED c41de797-89db-46fb-9d77-c52659edbe00 61 fields · synced May 18, 2026
- EUDAMED 2597484d-d4b2-4e9a-89c4-2205b9955e25 61 fields · synced May 18, 2026