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β2-Microglobulin Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass B (EU MDR)
Ref 105-004643-00Model Please see UDI-DI for details
Identity
- Trade Name
- β2-Microglobulin Kit (Latex Immunoturbidimetric Method) EUDAMED
- Device Name
- β2-Microglobulin Kit (Latex Immunoturbidimetric Method)、β2-Microglobulin Calibrator、β2-Microglobulin Control EUDAMED
- Model / Reference
- Please see UDI-DI for details EUDAMED105-004643-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904053653 EUDAMED
- Basic UDI-DI
- 69449040004MB2-MG******2U EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
Category: Beta-2-microglobulin IVD, reagent
β2-Microglobulin Kit (Latex Immunoturbidimetric Method) by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Class B — IVDR — listed in EUDAMED
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Also classified as Beta-2-microglobulin IVD, reagent.
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- 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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69449040004MB2-MG******2U | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 6afcad42-56af-40ee-a022-ca72fbdb5e6e 61 fields · synced Jun 18, 2026