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β2-Microglobulin (β2-MG) Assay Kit (Immunonephelometric Method)
EUDAMEDClass IVD General (EU MDR)
Ref R1: 2×40 mL, R2: 1×20 mL
Identity
- Device Name
- β2-Microglobulin (β2-MG) Assay Kit (Immunonephelometric Method) EUDAMED
- Model / Reference
- R1: 2×40 mL, R2: 1×20 mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937287300476 EUDAMED
- Basic UDI-DI
- B-06937287300476 EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
β2-Microglobulin (β2-MG) Assay Kit (Immunonephelometric Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in EUDAMED
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Also classified as Beta-2-microglobulin IVD, reagent.
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- Beta2-microglobulin urine — Diagam S.A. · IVD General
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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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06937287300476 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen AmTech Bioengineering Ltd., Inc.
- EUDAMED SRN
- CN-MF-000043067
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 23771a12-380a-4f27-9899-eaf9cf80c9cd 61 fields · synced Jul 8, 2026
- EUDAMED 23771a12-380a-4f27-9899-eaf9cf80c9cd-1 61 fields · synced Jun 10, 2026
- EUDAMED 23771a12-380a-4f27-9899-eaf9cf80c9cd-2 61 fields · synced Jun 10, 2026